Prodisc C Vivo PDVXL5Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00843193113795), received between Oct 24, 2023 and Sep 16, 2026 — classified as 6 injuries, 1 malfunction.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Migration

  A patient was implanted with a 2-level Prodisc C Vivo device below a fusion at C5-7 on (b)(6) 2026. There was no report of patient pain or other symptoms. However, imaging showed that the implant at C5-6 had migrated anteriorly. The implant was removed from C5-6 on (b)(6) 2026 and replaced with a Prodisc C Nova device.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50783245 ↗
• MalfunctionFeb 6, 2025Osseointegration Problem; Migration; Osseointegration Problem; Migration

  A PATIENT WAS IMPLANTED WITH A PDC VIVO DEVICE AT C4-5 AND TWO PDC SK DEVICES AT C5-6 AND C6-7 ON (B)(6) 2024 . IT WAS FOUND THAT THE VIVO IMPLANT HAD MIGRATED ANTERIORALLY, THE SK IMPLANT AT C5-6 WAS KYPHOTIC, AND THE SK IMPLANT AT C6-7 HAD MIGRATED POSTERIORALLY AND SUBSIDED. A SECOND SURGEON RECOMMENDED REMOVING ALL THREE LEVELS AND FUSING C6-7, AND CONVERTING C4-5 AND C5-6 TO PDC ORIGINAL. NO ADDITIONAL INFORMATION WAS PROVIDED AND IT IS UNKNOWN IF THE PATIENT RECEIVED ANY ADDITIONAL SURGICAL INTERVENTION.

  Patient problems: Spinal Column Injury

  MAUDE report 21326997 ↗
• InjuryDec 13, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH TWO PRODISC C VIVO IMPLANTS AT LEVELS C5-6 AND C6-7 ON (B)(6) 2024. PATIENT WAS ASYMPTOMATIC AND AT A ROUTINE FOLLOW UP IT WAS FOUND THAT THE BOTTOM LEVEL HAD MIGRATED. SURGEON REMOVED BOTH IMPLANTS ON (B)(6) 2024 AND FUSED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929529 ↗
• InjuryDec 13, 2024Migration; Migration

  PATIENT WAS IMPLANTED WITH TWO PRODISC C VIVO IMPLANTS AT LEVELS C5-6 AND C6-7 ON (B)(6) 2024. PATIENT WAS ASYMPTOMATIC AND AT A ROUTINE FOLLOW UP IT WAS FOUND THAT THE BOTTOM LEVEL HAD MIGRATED. SURGEON REMOVED BOTH IMPLANTS ON (B)(6) 2024 AND FUSED THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20929338 ↗
• InjuryMar 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS IMPLANTED WITH TWO PDC VIVO DEVICES AT LEAVE C5-6 AND C6-7 ON (B)(6)2023. ON (B)(6)2024, THE SURGEON REMOVED ONE LEVEL AND CONVERTED IT TO A FUSION PLATE SYSTEM. NO REASON FOR REMOVAL WAS PROVIDED, AND NO PATIENT SYMPTOMS ARE KNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18950073 ↗
• InjuryOct 24, 2023Fracture; Fracture

  PATIENT WAS IMPLANTED WITH TWO PRODISC C VIVO IMPLANTS AT LEVELS C3-4 AND C6-7 ON (B)(6) 2023. PATIENT MAY HAVE HAD A SLIP AND FALL TRAUMA THAT RESULTED IN A FRACTURE IN THE DEVICE. THIS LEAD TO INCREASED NECK PAIN WITH KYPHOSIS POSTERING. THE IMPLANT WAS REMOVED (B)(6) 2023 AND REPLACED WITH A CAGE AND PLATE SYSTEM.

  Patient problems: Neck Pain

  MAUDE report 17994721 ↗
• InjuryOct 24, 2023Fracture; Fracture

  PATIENT WAS IMPLANTED WITH TWO PRODISC C VIVO IMPLANTS AT LEVELS C3-4 AND C6-7 ON (B)(6) 2023. PATIENT MAY HAVE HAD A SLIP AND FALL TRAUMA THAT RESULTED IN A FRACTURE IN THE DEVICE. THIS LEAD TO INCREASED NECK PAIN WITH KYPHOSIS POSTERING. THE IMPLANT WAS REMOVED (B)(6) 2023 AND REPLACED WITH A CAGE AND PLATE SYSTEM.

  Patient problems: Neck Pain

  MAUDE report 17994670 ↗

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