Prodisc C Vivo PDVMD5Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00843193113702), received between Jul 1, 2024 and May 8, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Migration” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT (42YO, FEMALE) WAS IMPLANTED WITH A PDC VIVO DEVICE AT C5-6 ON (B)(6) 2026. NO INFORMATION ON PATIENT SYMPTOMS WAS PROVIDED. HOWEVER, IT WAS STATED THAT THE POSTERIOR AREA MAY NOT HAVE BEEN ADDRESSED WELL ENOUGH AND ADDITIONALLY THAT THE IMPLANT WAS REMOVED ON (B)(6) 2026 AND THE PATIENT WAS CONVERTED TO A THREE LEVEL FUSION SO THERE MAY HAVE BEEN OTHER AFFECTED LEVELS. HOWEVER, NO REASON FOR REMOVAL WAS CONFIRMED.

  Patient problems: Insufficient Information

  MAUDE report 25124277 ↗
• 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 23016692 ↗
• InjuryOct 14, 2024Migration; Migration

  A PATIENT WAS IMPLANTED WITH TWO PDC VIVO DEVICES ON (B)(6) 2024. AT A FOLLOW UP IT WAS FOUND THAT ONE OF THE LEVELS HAD MIGRATED, THE SURGEON COMPLETED A REMOVAL OF LEVEL C5-6 AND FUSED THAT SEGMENT ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20438956 ↗
• InjuryJul 16, 2024Migration; Migration

  A PATIENT WAS IMPLANTED WITH A PRODISC C VIVO IMPLANT ON (B)(6) 2023. PATIENT WAS EXPERIENCING PAIN AND IT WAS FOUND THAT THE IMPLANT HAD MIGRATED ANTERIORLY. THE SURGEON REMOVED THE IMPLANT ON (B)(6) 2024 AND THE PATIENT WAS FUSED.

  Patient problems: Pain

  MAUDE report 19751237 ↗
• InjuryJul 1, 2024Migration; Migration

  A PATIENT RECEIVED TWO PRODISC C VIVO IMPLANT ON (B)(6) 2023. ONE OF THE IMPLANTS WAS FOUND TO BE DISPLACED AND WAS CAUSING RADICULOPATHY IN THE PATIENT. NO DEVICE FAILURE INDICATED. THE DISPLACED IMPLANT WAS REMOVED ON (B)(6) 2024 AND REPLACED WITH A SEASPINE IMPLANT.

  Patient problems: Limb Pain

  MAUDE report 19650387 ↗

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