ProDisc-C 09.820.045SRecalls & reported problems
Synthes (U.S.A.) LP · PRODISC-C IMPLANT LARGE 5MM-STERILE · Class 3 · Implant
All models of ProDisc-C (11)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034763781), received between Nov 9, 2018 and Nov 9, 2018 — classified as 1 injury.
4 other recalls cover devices cleared under the same FDA submission (P070001); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryNov 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED PATIENT WAS IMPLANTED WITH PRODISC-C AT C6-C7 ON (B)(6) 2017. PATIENT REPORTED CONTINUED NECK PAIN AND WAS RETURNED TO SURGERY ON (B)(6) 2018 FOR REMOVAL OF THE PRODISC-C IMPLANT AND REVISED TO SPINAL FUSION. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO HARM TO PATIENT. PATIENT STATUS REPORTED AS STABLE. THIS REPORT IS FOR ONE (1) PRODISC-C IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Pain
MAUDE report 8055231 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under P070001. One submission often covers many models, so check the product and lot details in each record.
- Z-2050-2026 · Mar 20, 2026 · Open, ClassifiedProdisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
- Z-2051-2026 · Mar 20, 2026 · Open, ClassifiedProdisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
- Z-1426-2026 · Dec 31, 2025 · Open, ClassifiedBrand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No
- Z-1406-2021 · Mar 5, 2021 · TerminatedProdisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for
Other PROSTHESIS, INTERVERTEBRAL DISC devices
- Prodisc C SK PDSM5Centinel Spine, LLC · Prosthesis, Intervertebral Disc2 recalls4 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall12 reports
- Prodisc C 09.820.055SCentinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall9 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall4 reports
- Prodisc C SK PDSXL5Centinel Spine, LLC · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
- Simplify® Cervical Artificial DiscNuvasive, Inc. · Prosthesis, Intervertebral Disc1 recall3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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