Prodisc C Vivo PDVLD6Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00843193113771), received between Dec 22, 2025 and Mar 4, 2026 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT (40 YEARS, MALE) WAS IMPLANTED WITH TWO PRODISC C VIVO DEVICES AT C5-6 AND C6-7 ON (B)(6) 2025. AT THREE MONTHS POST IMPLANTATION THE PATIENT WAS STILL EXPERIENCING NECK PAIN. THE SURGEON REMOVED BOTH DEVICES AND COMPLETED AN ACDF AT C5-7 ON (B)(6) 2026.

  Patient problems: Neck Pain

  MAUDE report 24512106 ↗
• InjuryMar 4, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT (40 YEARS, MALE) WAS IMPLANTED WITH TWO PRODISC C VIVO DEVICES AT C5-6 AND C6-7 ON (B)(6) 2025. AT THREE MONTHS POST IMPLANTATION THE PATIENT WAS STILL EXPERIENCING NECK PAIN. THE SURGEON REMOVED BOTH DEVICES AND COMPLETED AN ACDF AT C5-7 ON (B)(6) 2026.

  Patient problems: Neck Pain

  MAUDE report 24506273 ↗
• InjuryDec 22, 2025Migration; Migration

  A PATIENT WAS IMPLANTED WITH A PRODISC C VIVO DEVICE AT LEVEL C5-6 ON (B)(6) 2025. AT A FOLLOW UP APPOINTMENT, IT WAS FOUND THAT THE IMPLANT HAD MIGRATED POSTERIORLY. ALTHOUGH THE PATIENT WAS ASYMPTOMATIC THE DECISION WAS MADE, AND THE IMPLANT WAS REMOVED ON (B)(6) 2025. THE PATIENT WAS CONVERTED TO AN ACDF.

  Patient problems: Insufficient Information

  MAUDE report 23864458 ↗

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