Abstract
Purpose To investigate the associations between cervical disc arthroplasty (CDA) design parameters (constraint and material composition) and complications necessitating revision surgery, by analyzing data from the Food and Drug Administration’s Manufacturer and User Facility Device Experience reports, with the goal of identifying potential links between specific design features and complications leading to revision surgery.
Methods Complication reports for 9 Food and Drug Administration–approved CDAs were retrospectively extracted from the Manufacturer and User Facility Device Experience database from January 2005 to September 2023. Each report was reviewed for potential revision surgery, CDA utilized, and the reported biomechanical complications. Devices were then compared for associated complications based on their constraints and material compositions.
Results A total of 478 revision cases exhibiting biomechanical complications were included. The most common complication associated with revision surgery was migration, in a total of 164 cases (34.4%), followed by heterotopic ossification in 46 cases (9.6%) and osteolysis in 45 cases (9.4%). When categorizing for constraint or material composition, migration emerges as the primary complication associated with revision surgery for nonconstrained (28.4%) and semiconstrained (30.7%), as well as metal-on-metal (33.3%) and metal-on-polyethylene (41.1%) designs. Meanwhile, for polyetheretherketone-on-ceramics (PoC) and viscoelastic (VC) designs, osteolysis appeared as the most relevant complication in revision cases (PoC: 40% and VC: 28.1%).
Conclusion Migration emerges as the primary biomechanical complication necessitating CDA revision surgeries, regardless of constraint design. Notably, newer materials (PoC and VC designs) demonstrate a shift toward osteolysis as the predominant complication, diverging from the patterns observed in traditional materials, where migration remained the dominant complication associated with metal-on-metal and metal-on-polyethylene revision surgery.
Clinical Relevance Knowledge of device-specific complication profiles—particularly that migration predominates in traditional CDA designs while osteolysis prevails in newer PEEK-on-ceramic and viscoelastic implants—can guide surgeons in implant selection and postoperative surveillance strategies.
Level of Evidence 4.
Introduction
Cervical disc arthroplasties (CDAs) have been developed to preserve the motion of the cervical segment while reducing stress on adjacent segments for patients suffering from cervical degenerative disease.1 Comparable clinical outcomes and lower rates of revision surgery, when compared with anterior cervical discectomy and fusion, have been reported.2–7 However, despite effectively relieving patient symptoms, numerous CDA devices feature different design concepts that may present with complications such as subsidence, migration, osteolysis, and heterotopic ossification (HO).8
Two strategies have been commonly employed when classifying CDAs and are either categorized based on their constraint, such as nonconstrained or semiconstrained, or based on their material compositions, such as metal-on-metal (MoM), metal-on-polyethylene (MoP), polyetheretherketone (PEEK)-on-ceramics (PoC), or viscoelastic (VC).2,9,10
Nonconstrained implants do not have check reins to motion in a particular degree of freedom, meaning that despite this feature, they have been criticized because they can potentially lead to extra loading of the facets.2,9–11 Semiconstrained implants are designed to replicate the motion of the cervical spine by offering a physiologically mobile axis of rotation with an increased range of motion while providing additional stability in instances of excessive motion.1,9
Materials commonly used for CDAs are metal, polymers, ceramics, and VC cores.2 Optimal criteria for these materials include preservation of kinematics and biomechanics, maintaining intervertebral space, biocompatibility, ease of revision if needed, and longevity.12 In recent years, the development of new promising PoC designs that incorporate PEEK endplates and ceramic cores has become available.13 The use of ceramics in arthroplasty has long been established, particularly in total hip implants, but is a novel material for CDA designs.14 VC devices represent an advancement in CDA design, engineered to emulate the biomechanical properties of native intervertebral discs.15 These implants incorporate compressible components, composed of polyurethane polymers or polycarbonate urethanes, which are designed to exhibit mechanical stiffness and VC behavior analogous to that of a natural cervical disc.15–17
Selecting a CDA design, including its constraint and material composition, results in different biomechanical sequelae, consequently affecting clinical performance and the likelihood of revision surgery.2 However, the literature on biomechanical CDA design parameters and related complications is limited. When examining complications that necessitate revision surgery following CDA, only a limited number of studies provide detailed accounts of the specific complications that lead to revision, often without disclosing the implant design.18 The scarcity of data fuels ongoing debate about optimal CDA design, including the role of constraint and material composition.
The US Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database contains records of complications associated with medical devices, including CDAs dating back to 1993.19 While the entries are submitted voluntarily, it is mandatory for device manufacturers, importers, and user facilities such as hospitals and ambulatory surgical centers to report any known complications associated with implants. The database contains information on different types of CDA and provides detailed descriptions of associated complications.
The purpose of this study was to examine complications associated with CDA revision cases concerning the design parameters of constraint and material combination utilizing data from MAUDE reports.
Methods
A retrospective analysis of the MAUDE database was performed, examining all complications associated with CDAs, specifically those leading to revision surgery due to biomechanical complications.
The data from the MAUDE database were retrieved on 1 October 2023, encompassing all adverse events reported between 1 January 2005 and 30 September 2023. The search included all 9 Food and Drug Administration-approved devices: Bryan (Medtronic, Memphis, TN, USA), Mobi-C (Zimmer Biomet, Austin, TX, USA), M6-C (Orthofix, Lewisville, TX, USA), Discover (DePuy Synthes, Raynham, MA, USA), Prestige (Medtronic, Memphis, TN, USA), ProDisc-C (Synthes, West Chester, PA, USA), Secure-C (Globus Medical, Audubon, PA, USA), and Simplify (SpinalMotion, Mountain View, CA, USA).1
Analysis of Entries
Each entry in the database includes the event date, a manual description of the event, report number, manufacturer, device model (including the brand name), and the complication reported. All entries underwent individual manual review, including criteria such as patients undergoing revision surgery and the particular complication involved. Furthermore, entries unrelated to CDA, duplicates, and those originating from social media were excluded from the analysis.
Each entry was categorized according to the reported complication mentioned in the event text. Thirteen types of biomechanical complications associated with revision surgery were defined (Table 1). Revision was defined as any secondary surgical intervention, including removals, reoperations, or supplemental fixation at the index level.
Definition of and examples of complications associated with revision surgeries.
Categorization
The entries for revision cases were categorized according to the type of implant utilized. Subsequently, the implants were further classified into 2 groups based on either material or constraint. The first categorization was based on the constraint of each implant being either “nonconstrained” or “semiconstrained” (Table 2).1,2 Because PCM devices have either a semiconstrained or nonconstrained model but the model was not indicated in the MAUDE database, they were omitted from this grouping.20 The second classification of the 9 different implants was based on the material combination used to manufacture the implant, resulting in 4 distinct groups: MoM, MoP, PoC, and VC (Table 3).1,21
Grouping different cervical disc arthroplasty designs based on their type of constraint (N = 436 a ).
Grouping different cervical disc arthroplasty designs based on implant material combination (N = 478).
Quantitative Analysis
All reported entries indicating revision surgery were sorted by type of device and the year they were reported. All revision cases were analyzed based on the associated reported complication. Every complication was analyzed based on the device’s constraint and material combination.
Statistical Analysis
Counts and percentages were calculated for all the categorical variables and sorted in descending order. Statistical analysis was performed using RStudio version 2023.09.
Results
Initially, 2000 entries were extracted from the MAUDE database, and 1347 cases were selected for in-depth analysis. Among these, 669 entries were duplicates, had insufficient information, or were reported via social media by patients and were thus excluded. An additional 200 revision cases were associated with nonbiomechanical complications, such as neck pain, arm pain, or infection, and were excluded. Therefore, 478 revision cases remained for analysis.
All Revision Cases
The most commonly associated complication requiring revision was migration, accounting for 164 cases (34.4%), followed by HO with 46 cases (9.4%) and osteolysis with 45 cases (9.4%). The number of reported revision cases per complication is detailed in Table 4.
Complications associated with revision surgery (N = 478).
Constraint
A total of 436 out of 478 (91.2%) entries featured implants categorized as either nonconstrained or semiconstrained. Within these cases, 296 (67.9%) cases were reported for the nonconstrained group, while the semiconstrained group comprised 140 (32.1%) cases.
Both constraint groups presented migration as the primary complication associated with revision surgery, with 84 (28.4%) in the nonconstrained and 43 (30.7%) in the semiconstrained group. The second most commonly reported complication for the nonconstrained group was osteolysis (n = 39; 13.2%), followed by implant breakage over time (n = 31; 10.8%). Meanwhile, the second and third most frequently reported complications for the semiconstrained devices were subsidence (n = 21; 15.0%) and HO (n = 18; 12.9%), respectively. A structured analysis of the complications presented for the nonconstrained and semiconstrained groups can be found in Tables 5 and 6, respectively.
Complications associated with revision surgery for nonconstrained devices (n = 196).
Complications associated with revision surgery for semiconstrained devices (n = 140).
Material
All 478 reported revision cases were categorized into 1 of the 4 material groups (MoM, MoP, PoC, or VC).
Metal-on-Metal
Forty-five revision cases (9.4%) of MoM devices were identified from the MAUDE database. Among these cases, the 3 most prevalent complications associated with revision were migration (n = 15; 33.3%), subsidence (n = 9; 20.0%), and HO (n = 4; 8.9%; Table 7).
Complications associated with revision surgery for metal-on-metal devices (n = 45).
Metal-on-Polyethylene
A total of 309 (64.6%) revision cases were reported for MoP devices, with migration (n = 127; 41.1%) followed by HO (n = 35; 11.3%) and subsidence (n = 30; 9.7%) most frequently associated with revision surgery (Table 8).
Complications associated with revision surgery for metal-on-polyethylene devices (n = 309).
PEEK-on-Ceramics
Ten revision cases (2.1%) were documented for PoC devices. The most frequent complications associated with revision surgery were osteolysis (n = 4; 40.0%), HO (n = 3; 30%), and migration (n = 2; 20.0%; Table 9).
Complications associated with revision surgery for polyetheretherketone-on-ceramics devices (n = 10).
Viscoelastic
One hundred fourteen revision cases (23.8%) were reported for VC devices, with the top 3 complications associated with revision being osteolysis (n = 32; 28.1%), followed by implant breakage over time (n = 22; 19.3%) and migration (n = 20; 17.5%; Table 10).
Complications associated with revision surgery for viscoelastic devices (n = 114).
Comparison of Constraint by Material
The MoP group reported 182 (38.1%) entries for nonconstrained and 85 (17.8%) semiconstrained devices for the different constraint types. Both subgroups presented with migration as the top complication (nonconstrained: n = 64; 34.8 %; semiconstrained: n = 26; 31.0%), followed by HO in the nonconstrained (n = 24; 13.3%), and adjacent segment disease (ASD; n = 12; 14.0%) and malposition (n = 12; 14.0%) as the second most commonly reported complication for the semiconstrained group. All other designs within the MoM, PoC, and VC groups were the same type of constraint that allowed the groups to be compared within each material group.
Discussion
A total of 478 revision cases for CDAs reported to the MAUDE database were analyzed, focusing on 2 design parameters: constraint and material composition. The findings revealed that migration was the predominant complication necessitating revision surgery for both nonconstrained and semiconstrained devices, as well as for 2 of the 4 bearing material combinations (MoM and MoP). This is in alignment with previous studies analyzing the MAUDE database, showing migration as the most reported complication, independent of whether patients underwent revision surgery.22 Notably, our investigation revealed a distinct pattern in newer material compositions (PoC and VC designs), where osteolysis emerged as the predominant complication.
Constraint
When comparing nonconstrained to semiconstrained devices, nearly twice as many cases were revised due to segmental instability in nonconstrained CDA devices (8.4% vs 4.3%). This underscores the inherent instability of nonconstrained CDAs and highlights the challenges associated with selecting the appropriate level of constraint for individual patients. Furthermore, ASD had a relatively high association for revision cases with 10.7%, whereas it was rare in nonconstrained CDA devices (1%). Hence, the incidence of ASD appears to be mitigated in patients undergoing nonconstrained CDA. In contrast, this effect has not appeared as pronounced in semiconstrained designs, supporting the hypothesis that motion preservation may protect the adjacent segment.4,23 Furthermore, a relevant portion (10.8%) of revision surgery for nonconstrained devices resulted from implant breakage, matching several case reports describing cracks in the polyurethane sheath or anterior tipping of the device leading to symptomatic segmental kyphosis.24,25 However, fewer cases of implant breakage (2.9%) were reported in semiconstrained devices in the findings presented here.
Considering that the migration rate did not differ for both types of constraint, this may suggest challenges in controlling motion segment kinematics through implant design. The findings of this study provide important new insights into the issue of migration, a well-documented complication in CDA.26 While previous research has suggested that constrained CDA devices may offer better resistance to migration compared with semiconstrained designs, the results of this study challenge that generalization.6 Migration emerged as the primary complication regardless of constraint design, indicating that the device architecture alone may not be the sole determining factor. There is only 1 report of a semiconstrained device that found no device migration in 380 patients within 24 months after surgery. This finding does not align with the MAUDE database, as potentially the study has set a 3 mm threshold for the magnitude of CDA migration, whereas MAUDE has no migration thresholds.
Osteolysis emerged as the second most common complication within revision surgery, where 13.2% were found in nonconstrained and 4.3% in semiconstrained devices. The likelihood of more significant debris generation with nonconstrained devices might stem from the greater sliding distances between the bearing surfaces in unconstrained motion, similar to the effect of more significant head sizes in total hip arthroplasty.27 A clinical study of a nonconstrained CDA supports elevated rates of osteolysis, with 34% (18 of 53) of patients at 67 months postoperatively.28
HO was ranked fourth in nonconstrained and third in semiconstrained devices with regard to its association with revision surgery. When aligning the current literature on semiconstrained devices, a reported value of 9.1% of spontaneous fusion rates within 1 year after surgery was detected. Meanwhile, nonconstrained devices report a 16.0% rate of complete fusion after 2 years.29,30 This complication appears to be relatively less common as a reason for revision surgery, potentially because HO is a radiographic phenomenon and may necessarily correlate with clinical outcomes.29,31
Material Composition
MoM represents the first generation of CDAs and was partially replaced by MoP devices over time; nevertheless, both designs exhibit comparable complication profiles linked to revision surgery, including migration, subsidence, and HO. When comparing MoM to MoP, a systematic review found that the MoM cohort exhibited a higher proportion of patients with relevant ASD necessitating revision.32 The same study stated a higher incidence of HO in MoM. However, the rate of patients presenting with symptomatic HO was significantly higher in the MoP group. Similarly, our findings report that HO is 1 of the top 3 complications for both MoP and MoM devices (11.3% for MoP and 8.9% for MoM).32 This finding aligns with MAUDE reports, where ASD was associated with 6.7% of MoM but only 3.9% of MoP revision cases. However, our findings do not represent incidences, and therefore, direct comparison is limited. Hence, the connection between HO and the requirement for revision surgery might be more relevant for MoP bearings.
PoC devices were developed to integrate the benefits of ceramic-PEEK bearings used in hip replacements, which have been demonstrated to reduce wear significantly.33 Indeed, biomechanical testing of PoC devices showed an acceptable wear profile.13 Nonetheless, osteolysis was the most frequently reported complication in revision cases for PoC devices in the MAUDE database. Similarly, ceramic hip replacements presented with periprosthetic osteolysis were proposed as a foreign-body response to wear particles.34
VC devices presented with osteolysis were the most common complication associated with 28.1% of the reported revisions, aligning with several clinical studies describing high rates of wear-induced osteolysis for VC devices.28 Additionally, retrieval analysis of VC devices showed chronic inflammatory responses with intracellular polymeric debris.35 The observed wear may be explained by the conjunction of high-strength materials with VC materials, creating a vulnerability at the interface. Additionally, most elastomeric materials lack an orthopedic history, making their long-term behavior uncertain.15 Interestingly, VC devices showed a relatively low rate (3.5%) of revisions associated with HO compared with other materials. This aligns with clinical findings of low HO rates (6.7%) at 12-month follow-up, where markedly higher rates were found for non-VC devices.28,36
Limitations
The data presented in the present article do not represent the incidence of complications but focus on describing types of complications in revision cases associated with CDA design parameters. Furthermore, isolating the effects of constraint and material combinations remains challenging since each design incorporates a blend of both factors. In addition, many other factors influence the biomechanical properties of a CDA.10 The MAUDE database relies on voluntary reporting, which may introduce bias by potentially underrepresenting the true incidence of complications or iatrogenic events for each device. Due to the lack of comprehensive data on the total number of implanted devices, this analysis is limited to providing individualized interpretations of the results and precludes direct comparisons between different devices. Therefore, it is neither feasible nor appropriate to draw conclusions about the absolute number of revision cases or overall complication rates based solely on this data. Furthermore, the absence of temporal data on complications limits the study’s ability to account for the evolution of implant designs and the time-dependent nature of specific issues, potentially affecting the interpretation of results across different device generations. Finally, drawing conclusions for specific design elements is challenging due to the limited diversity of CDA designs in some categories, with certain types represented by only a single device and few reported complications. Nonetheless, with the lack of comparative clinical results, the MAUDE database provides insights into CDA revision cases and has been used in many studies exploring the performance of medical devices.22,37,38
Conclusion
The device’s constraint does not change the primary complication of migration; however, nonconstrained devices demonstrate a greater relevance of osteolysis and implant breakage over time. In semiconstrained designs, complications such as subsidence and HO seem more relevant. Furthermore, semiconstrained devices exhibit a higher relevance of ASD revision cases than nonconstrained devices. Hence, maintaining the maximum degrees of freedom (DOF) might influence the risk of revision surgery due to ASD. When looking at different material compositions, MoM and MOP designs exhibit comparable complication profiles linked to revision surgeries, including migration, subsidence, and HO. Osteolysis is the dominant complication in revision cases for both PoC and VC. However, the small sample size for PoC and VC designs warrants further investigation to validate and expand upon these initial observations with larger-scale studies. While PoC devices exhibit a higher incidence of HO similar to their metallic counterparts (MoM and MoP), the revision surgeries required for VC implants show a notably low rate of complications attributed to HO.
In conclusion, migration emerges as the primary biomechanical complication necessitating CDA revision surgeries, regardless of constraint design. However, newer materials (PoC and VC designs) demonstrate a shift toward osteolysis as the predominant complication, diverging from the patterns observed in traditional materials.
Footnotes
Funding This study was funded by a research grant by the Rama and Shashi Marda Foundation.
Declaration of Conflicting Interests The authors do not have a conflict of interest in this study.
Author Contributions F.C.S.A. and D.R.L. conceived and designed the study. F.C.S.A., M.J.K., and F.A. collected and analyzed the data. J.Z. performed the statistical analysis. C.A. and T.M.W. provided technical expertise and supervised the biomechanical aspects of the study. F.C.S.A. drafted the initial manuscript. All authors contributed to the interpretation of results, critically revised the manuscript for important intellectual content, and approved the final version for publication.
Disclosures The authors do not have a conflict of interest in this study. F.C.S.A., M.J.K., F.A., and J.Z. have no industry relations. C.A. is a consultant for the Advisory Board for Camber Spine Tech; a consultant for Centinel Spine, Inc.; and is on the Advisory Board and has an ownership interest in Orthobond Corporation and Surgalign. D.R.L. is a consultant and on the Advisory Board for Choice Spine; is a consultant for DePuy Synthes; has an ownership interest from Woven Orthopedic Technologies, Vestia Ventures MiRus Investment LLC HS2, LLC, and ISPH II, LLC; has received research support from Medtronic Sofamor Danek USA, Inc.; receives royalties from Nuvasive, Inc; is on the Advisory Board and has ownership interest from Remedy Logic; is a consultant and receives royalties from Stryker; and is a consultant and has ownership interest from Viseon, Inc.
Ethical Approval Ethical approval was not required for this study as all data were obtained from publicly available databases, with no direct involvement of human participants or access to identifiable personal information.
- This manuscript is generously published free of charge by ISASS, the International Society for the Advancement of Spine Surgery. Copyright © 2026 ISASS. To see more or order reprints or permissions, see http://ijssurgery.com.
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