Prodisc C 09.820.035SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843193112781), received between Jun 30, 2020 and May 3, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• InjuryMay 3, 2023Migration or Expulsion of Device; Malposition of Device; Migration or Expulsion of Device; Malposition of Device

  IT WAS REPORTED THAT A PATIENT RECEIVED A PRODISC C IMPLANT ON (B)(6) 2022. THE PATIENT EXPERIENCED INCREASED NECK AND ARM PAIN AND AN X-RAY FOUND THAT THERE WAS A CHANGE IN IMPLANT POSITION RESULTING IN KYPHOSIS AND FISH MOUTHING OF THE IMPLANT. A PRODISC C REMOVAL WAS COMPLETED ON (B)(6) 2023. PATIENT WAS REVISED BY A CORELINK 3D PRINTED TITANIUM CAGE.

  Patient problems: Neck Pain

  MAUDE report 16859741 ↗
• InjurySep 24, 2021Migration; Migration

  PATIENT RECEIVED A PRODISC C US IMPLANT MEDIUM DEEP 5MM ON (B)(6) 2021 IN THE C5/6 DISC SPACE. FOLLOW UP IMAGING REVEALED THE PRODISC C DEVICE MIGRATED ANTERIORLY. LATERAL X-RAYS PROVIDED CONFIRM THIS REPORTED MALFUNCTION. THE PATIENT WAS SCHEDULED FOR REMOVAL TO PRECLUDE SERIOUS INJURY. THERE WAS NO INDICATION OF PATIENT COMPLICATIONS OR SYMPTOMS. THERE WERE NO REPORTED COMORBIDITIES OR PRE-EXISTING CONDITIONS. ON (B)(6)2021 THE PRODISC C DEVICE WAS REMOVED AND CONVERTED TO A FUSION. THERE WERE NO INDICATIONS OF COMPLICATIONS DURING THE REMOVAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526721 ↗
• InjuryJun 30, 2020Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility

  A PATIENT REQUIRED SURGICAL INTERVENTION TO REMOVE A PRODISC C IMPLANT DUE TO CONTINUED PAIN. THE PATIENT WAS EXPERIENCING PAIN, SPECIFICALLY WHEN LOOKING UP. THIS PATIENT WAS IMPLANTED WITH THE DEVICE ON (B)(6) 2019. THE SURGEON INDICATED THAT THE IMPLANTED PRODISC C DEVICE WAS TOO TALL DESPITE BEING A 5MM (SHORTEST) HEIGHT IMPLANT.

  Patient problems: Neck Pain

  MAUDE report 10212572 ↗

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