Prodisc C Vivo PDVLD5Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00843193113764), received between Dec 13, 2023 and Jul 1, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Migration” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Migration

  A PATIENT WAS IMPLANTED WITH A PDC VIVO DEVICE AT LEVEL C6-7 ON (B)(6) 2025. IT WAS LATER FOUND THAT THE IMPLANT HAD MIGRATED POSTERIORLY. NO PATIENT SYMPTOMS WERE PROVIDED AND A REMOVAL WAS INITIALLY SCHEDULED AND THEN CANCELLED. NO MEDICAL INTERVENTION HAS BEEN NOTED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25681934 ↗
• InjuryMay 20, 2026Migration

  A PATIENT (40-YEAR-OLD MALE) WAS IMPLANTED WITH A PDC VIVO DEVICE AT LEVEL C5-6 ON (B)(6) 2025. IT WAS FOUND THAT THE IMPLANT HAD MIGRATED ANTERIORLY. IT IS UNKNOWN IF THE PATIENT WAS SYMPTOMATIC. THE VIVO WAS REMOVED ON (B)(6) 2026 AND WAS REPLACED WITH A PDC SK DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 25229823 ↗
• MalfunctionNov 14, 2025Migration; Migration

  A PATIENT WAS IMPLANTED WITH A PDC VIVO IMPLANT AT C6-7 ON (B)(6) 2025. AT THE TWO MONTH FOLLOW UP IT WAS FOUND THAT THE IMPLANT WAS IN A KYPHOTIC POSITION AND AT THE FOUR MONTH FOLLOW UP IT WAS FOUND THAT THE IMPLANT HAD MIGRATED POSTERIORLY.

  Patient problems: Insufficient Information

  MAUDE report 23555964 ↗
• InjuryFeb 27, 2024Osseointegration Problem; Osseointegration Problem

  A PATIENT WAS IMPLANTED WITH A PRODISC C VIVO IMPLANT ON (B)(6) 2022. PATIENT WAS EXPERIENCING SOME NECK PAIN AND ON A FOLLOW UP X-RAY IT WAS FOUND THAT THE POSTERIOR SIDE OF THE SUPERIOR ENDPLATE HAD SUBSIDED INTO THE VERTEBRAL BODY. THE IMPLANT WAS REMOVED ON (B)(6) 2024 AND THE PATIENT WAS CONVERTED TO AN ACDF CAGE AND PLATE SYSTEM.

  Patient problems: Neck Pain

  MAUDE report 18787468 ↗
• InjuryJan 16, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH THREE PRODISC C VIVO IMPLANTS ON (B)(6) 2023. MIDDLE LEVEL (C5/6) OF THE THREE LEVEL CONSTRUCT WAS FOUND TO HAVE MIGRATED ANTERIORLY. MIGRATED IMPLANT WAS REMOVED ON 28DEC2023. MIGRATED IMPLANT WAS REPLACED WITH A PRODISC C IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 18520851 ↗
• InjuryDec 13, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT AN IMPROMPTU PRODISC C VIVO REMOVAL WAS COMPLETED ON (B)(6) 2023.

  Patient problems: Limb Pain

  MAUDE report 18320261 ↗

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