Prodisc C Vivo PDVXL6Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00843193113801), received between Jun 16, 2026 and Aug 18, 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 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.

• InjuryAug 18, 2026Migration

  A patient was implanted with a Prodisc C Vivo device on (b)(6)2025. It is unknown if the patient experienced any symptoms, however, imaging showed that the implant had migrated. The implant was removed on (b)(6)2026 and the patient was fused.

  Patient problems: Insufficient Information

  MAUDE report 50305536 ↗
• InjuryJun 16, 2026Osseointegration Problem

  A PATIENT (76YO, MALE) WAS IMPLANTED WITH A PDC VIVO DEVICE AT C3-4 ON (B)(6) 2026. PATIENT HAD SYMPTOMS CONSISTENT WITH STENOSIS AND KYPHOSIS, AND IMPLANT SUBSIDENCE WAS SEEN ON IMAGING. THE VIVO WAS REMOVED ON (B)(6) 2026 AND REPLACED WITH A THREE LEVEL ACDF.

  Patient problems: Insufficient Information

  MAUDE report 25519961 ↗

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