Prodisc C Vivo PDVXLD5Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843193113825), received between Aug 22, 2024 and Oct 23, 2025 — 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 18, 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.

• InjuryOct 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH A PDC VIVO DEVICE AT C6-7 ON (B)(6) 2024. PATIENT HAD ON-GOING SYMPTOMS FROM PRIOR TO DEVICE IMPLANTATION. THE IMPLANT WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS GIVEN A 3 LEVEL FUSION.

  Patient problems: Insufficient Information

  MAUDE report 23366949 ↗
• InjuryAug 22, 2024Migration; Migration

  A PATIENT WAS IMPLANTED WITH TWO PDC VIVO IMPLANTS ON (B)(6) 2024. ONE IMPLANT WAS FOUND TO HAVE MIGRATED POSTERIORLY AND LATERALLY TO THE RIGHT. A PDC VIVO REMOVAL WAS COMPLETED ON (B)(6) 2024, PATIENT WAS CONVERTED TO A PDC SK AT C4-5. INITIAL PLACEMENT OF VIVO IMPLANT MAY HAVE BEEN SLIGHTLY MISPLACED.

  Patient problems: Insufficient Information

  MAUDE report 20039932 ↗

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