ProDisc-C 09.820.035SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034763750), received between Feb 8, 2018 and Jun 20, 2019 — classified as 3 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT C4/C5 PRODISC-C REMOVAL, DUE TO CONTINUED PATIENT PAIN AND FACET ARTHROSIS. ORIGINALLY, THE PATIENT UNDERWENT PDC IMPLANTATION ABOUT 6 YEARS AGO. THE PDC IMPLANT WAS SUCCESSFULLY EXPLANTED AND THE PATIENT WAS REVISED TO DEPUY SYNTHES ZERO-P FUSION, STAND-ALONE DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME WAS GOOD. THIS REPORT IS FOR ONE (1) PRODISC-C IMPLANT MEDIUM DEEP 5MM STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Arthritis; No Code Available; Pain

  MAUDE report 8718847 ↗
• InjuryOct 23, 2018Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT WAS IMPLANTED WITH PRODISC-C AT C5-C6 IN (B)(6) 2014.

  Patient problems: No Code Available

  MAUDE report 7997860 ↗
• InjuryFeb 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT IS EXPERIENCING A POSSIBLE DELAYED HYPERSENSITIVITY REACTION WITH "BIZARRE SYMPTOMS." SHE UNDERWENT A C5-C6 ARTIFICIAL DISC REPLACEMENT WITH PRO DISC-C ARTIFICIAL DISK ( 15 MM WIDE X 14 MM DEEP X 5MM HEIGHT) ON (B)(6) 2016. THE PATIENT IS SEEKING MATERIALS COMPOSITION FOR THE IMPLANT, AS SHE HAS BEEN REFERRED BY THE SURGEON FOR PATCH TESTING FOR A POSSIBLE DELAYED HYPERSENSITIVITY REACTION. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7253442 ↗

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