Prodisc C Vivo PDVMD6Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843193113719), received between Sep 10, 2025 and Apr 16, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Migration” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Migration

  A PATIENT WAS IMPLANTED WITH A PDC VIVO DEVICE AT LEVEL C3-4 ON (B)(6) 2025. THE PATIENT WAS EXPERIENCING A LITTLE BIT OF PAIN AND IT WAS FOUND THAT THE IMPLANT HAD MIGRATED ANTERIORLY. THE IMPLANT WAS REMOVED ON (B)(6) 2026 AND THE PATIENT WAS FUSED.

  Patient problems: Pain

  MAUDE report 24896406 ↗
• InjurySep 10, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  A PATIENT WAS IMPLANTED WITH TWO PRODISC C VIVO IMPLANTS AT C5-6 AND C6-7 ON (B)(6) 2024. PATIENT BECAME SYMPTOMATIC AND RECEIVED A FACET INJECTION IN (B)(6) 2024 TO NO SIGNIFICANT IMPROVEMENT. IT WAS FOUND THAT THE PATIENT HAD A PREVIOUSLY UNKNOWN NICKEL ALLERGY. A SECOND SURGEON REMOVED THE IMPLANTS ON (B)(6) 2025 AND REPLACED THEM WITH A NICKEL FREE DISC REPLACEMENT DEVICE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 23016680 ↗

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