Prodisc C SK PDSL5Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843193113917), received between Feb 20, 2025 and Aug 6, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  A PATIENT WAS IMPLANTED WITH A PDC SK AT C5-6 AND A PDC VIVO AT C6-7 ON (B)(6) 2025. THE PATIENT WAS FOUND TO HAVE A NICKEL ALLERGY AND REQUIRED THE IMPLANTS TO BE REMOVED. THE IMPLANTS WERE BOTH REMOVED ON (B)(6) 2025 AND THE PATIENT WAS FUSED AT BOTH LEVELS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22725964 ↗
• InjuryFeb 20, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  THE PATIENT WAS IMPLANTED WITH A PRODISC C SK DEVICE AT C5-6 ON (B)(6) 2023. THE TDR LEVEL WAS REPORTED AS BEING HYPER MOBILE AND CAUSING PAIN, SURGEON STATED THAT THE PATIENT SEEMED TO NEVER QUITE HEAL AND THAT THE IMPLANT SEEMED LOOSE UPON REMOVAL. THE SURGEON REMOVED THE SK IMPLANT AND FUSED THE PATIENT ON (B)(6) 2025. SURGEON SENT THE PATIENT FOR SEROLOGICAL ALLERGY SCREENING POST REMOVAL AND FUSION TO RULE OUT ANY UNREPORTED METAL ALLERGIES AND THE RESULTS CONFIRMED THAT THE PATIENT HAS A PREVIOUSLY UNDIAGNOSED LOW GRADE NICKEL ALLERGY WHICH THE SURGEON BELIEVES CAUSED THE NEED TO EXPLANT THE SK.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 21424076 ↗

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