Prodisc C 09.820.046SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00843193112828), received between Mar 2, 2022 and Mar 2, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 2, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT WHO WAS IMPLANTED ON (B)(6) 2021 WITH PRODISC C AT C5/6 HAS SUFFERED SUBSIDENCE OF THE PRODISC C IMPLANT. THERE WERE NO REPORTED PATIENT SYMPTOMS OR COMPLICATION. NO PATIENT COMORBIDITIES WERE INDICATED. NO DEVICE MALFUNCTION WAS INDICATED. THERE IS LIMITED INFORMATION AVAILABLE FROM THIS CASE. NO IMAGING WAS PROVIDED. ON (B)(6) 2022, THE PATIENT UNDERWENT REVISION TO REMOVE THE PRODISC C DEVICE AND REPLACE IT WITH AN M6 ARTIFICIAL CERVICAL DISC. THE SURGEON DID NOT PROVIDE A CLEAR INDICATION AS TO WHAT LED TO THE SUBSIDENCE OF THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13656230 ↗

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-2051-2026 · Mar 20, 2026 · Open, Classified
  Prodisc C SK U.S. IMPLANT EXTRA LARGE 6MM. Model Number: PDSXL6. Total cervical disc replacement.
• Z-2050-2026 · Mar 20, 2026 · Open, Classified
  Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
• Z-1426-2026 · Dec 31, 2025 · Open, Classified
  Brand 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 · Terminated
  Prodisc C - prosthesis, intervertebral disc - Product Usage: indicated in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for