ProDisc-C 09.820.066SRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034763859), received between Jun 1, 2018 and Jun 1, 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

Recent adverse event reports

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

• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY ON AN UNKNOWN DATE FOR TREATMENT WITH A (PDC) PRODISC C ARTIFICIAL DISC REPLACEMENT AT SPINE DISC LEVEL C4-C5. ALSO, THE PATIENT WAS IMPLANTED WITH UNKNOWN FUSION IMPLANTS AT DISC LEVELS C5-C6. IT IS UNKNOWN IF THE PDC IMPLANT AND THE FUSION IMPLANTS WERE IMPLANTED AT THE SAME TIME OR ON TWO SEPARATE PROCEDURES. ON AN UNKNOWN DATE POST-OPERATIVELY, THE PATIENT PRESENTED WITH A MYELOPATHY, ADJACENT LEVEL DISC DISEASE AND BROKEN SCREWS AT THE FUSION C5-C6 LEVELS. THE QUANTITY, TYPE, AND MANUFACTURER OF THE BROKEN FUSION SCREWS IMPLANTS ARE UNKNOWN. ON (B)(6) 2018, THE SURGEON REMOVED ALL IMPLANTS. INTER-OPERATIVE, DURING THE PDC REMOVAL STAGE OF THE PROCEDURE, IT WAS REPORTED THAT THE INFERIOR LOWER LEVEL END PLATE CAME OUT EASILY. THE PDC UPPER-END PLATE PROVED MORE DIFFICULT. DUE TO BONE GROWTH AROUND THE UPPER PLATE, ADDITIONAL DRILLING TIME WAS NEEDED. NO FRAGMENTS WERE GENERATED DURING REMOVAL. THE PATIENT WAS REVISED TO A TWO-LEVEL CORPECTOMY. REVISION SURGERY WAS COMPLETED SUCCESSFULLY. DUE TO THE PDC UPPER-END PLATE ISSUE, AN ADDITIONAL FIVE (5) MINUTES WAS ADDED TO OPERATING ROOM TIME. THE PATIENT IS REPORTED IN STABLE CO

  Patient problems: No Code Available

  MAUDE report 7562200 ↗

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, Classified
  Prodisc C SK U.S. IMPLANT EXTRA LARGE 5MM. Model: PDSXL5 Total cervical disc replacement.
• 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-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