Prodisc C Vivo PDVL5Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00843193113733), received between Jun 21, 2023 and Sep 15, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration” (11 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 15, 2026Migration

  A patient was implanted with a 2-level Prodisc C Vivo device on (b)(6) 2025. The patient reporting having neck pain. Imaging showed that the implant had migrated anteriorly and possible osteolysis. The implants were removed on (b)(6) 2026 and the patient was fused.

  Patient problems: Neck Pain

  MAUDE report 50773739 ↗
• InjuryJul 29, 2026Migration

  A patient was implanted with a Prodisc C Vivo device at C5-6 on (b)(6) 2025. The patient was experiencing neck pain. It was found that the superior endplate had migrated anteriorly. The implant was removed on (b)(6) 2026 and the patient was fused.

  Patient problems: Neck Pain

  MAUDE report 50073418 ↗
• InjuryJun 5, 2026Migration

  A PATIENT (53 YO, FEMALE) WAS IMPLANTED WITH A PDC VIVO DEVICE AT LEVEL C5-6 ON (B)(6) 2024. THE PATIENT WAS EXPERIENCING NECK PAIN AND MILD RIGHT ARM PAIN. IT WAS FOUND THAT THE IMPLANT HAD MIGRATED ANTERIORLY. THE IMPLANT WAS REMOVED ON (B)(6) 2026 AND THE PATIENT WAS FUSED.

  Patient problems: Limb Pain; Neck Pain

  MAUDE report 25407547 ↗
• MalfunctionMay 5, 2026Migration

  A PATIENT (54YO, MALE) WAS IMPLANTED WITH A PDC VIVO DEVICE AT LEVEL C6-7 IN (B)(6) 2025. AT 3 MONTHS POSTOP IT WAS FOUND THAT THE IMPLANT HAD MIGRATED.

  Patient problems: Insufficient Information

  MAUDE report 25087094 ↗
• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH A PDC VIVO DEVICE ON (B)(6) 2025. IT WAS STATED THAT THE PATIENT HAD NO REAL SYMPTOMS BUT THAT THE SURGEON JUST DECIDED TO FUSE. THE IMPLANT WAS REMOVED ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 23631438 ↗
• InjuryNov 14, 2025Migration; Migration

  A PATIENT WAS IMPLANTED WITH TWO PRODISC C VIVO DEVICES ON (B)(6) 2024. IT WAS FOUND THAT THE IMPLANTS WERE LOOSENING. THE VIVO DEVICES WERE REMOVED AND REPLACED WITH PRODISC C LEGACY DEVICES ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 23555978 ↗
• InjuryNov 12, 2025Migration; Migration

  A PATIENT WAS IMPLANTED WITH THREE PRODISC C VIVO IMPLANTS ON (B)(6) 2023. IT WAS FOUND THAT THE VIVO IMPLANTS APPEARED TO BE LOOSENING IN THE PATIENT. A REMOVAL WAS COMPLETED ON (B)(6) 2025 AND REPLACED WITH PRODISC C LEGACY DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 23538330 ↗
• InjuryNov 12, 2025Migration; Migration

  A PATIENT WAS IMPLANTED WITH THREE PRODISC C VIVO IMPLANTS ON (B)(6) 2023. IT WAS FOUND THAT THE VIVO IMPLANTS APPEARED TO BE LOOSENING IN THE PATIENT. A REMOVAL WAS COMPLETED ON (B)(6) 2025 AND REPLACED WITH PRODISC C LEGACY DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 23538308 ↗
• InjurySep 16, 2025Osseointegration Problem; Osseointegration Problem

  A PATIENT WAS IMPLANTED WITH A PRODISC C VIVO DEVICE ON (B)(6) 2023. THE PATIENT BEGAN TO EXPERIENCE A REOCCURRENCE OF ARM PAIN AND IT WAS FOUND THAT THE IMPLANT HAD SUBSIDED. THE SURGEON REMOVED THE IMPLANT ON (B)(6) 2025 AND FUSED THE PATIENT.

  Patient problems: Limb Pain

  MAUDE report 23062433 ↗
• InjuryAug 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  A PATIENT WAS IMPLANTED WITH A PDC SK AT C5-6 AND A PDC VIVO AT C6-7 ON (B)(6) 2025. THE PATIENT WAS FOUND TO HAVE A NICKEL ALLERGY AND REQUIRED THE IMPLANTS TO BE REMOVED. THE IMPLANTS WERE BOTH REMOVED ON (B)(6) 2025 AND THE PATIENT WAS FUSED AT BOTH LEVELS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22725959 ↗
• InjuryJul 14, 2025Migration; Migration

  A PATIENT WAS IMPLANTED WITH TWO PDC VIVO DEVICES ON (B)(6) 2024. IT WAS FOUND THAT BOTH IMPLANTS HAD MIGRATED ANTERIORLY. NO SYMPTOMS WERE REPORTED. THE DECISION WAS MADE TO REMOVE THE IMPLANTS, THE REMOVAL SURGERY WAS COMPLETED ON (B)(6) 2025 AND THE PATIENT WAS FUSED.

  Patient problems: Insufficient Information

  MAUDE report 22493817 ↗
• InjuryJul 14, 2025Migration; Migration

  A PATIENT WAS IMPLANTED WITH TWO PDC VIVO DEVICES ON (B)(6) 2024. IT WAS FOUND THAT BOTH IMPLANTS HAD MIGRATED ANTERIORLY. NO SYMPTOMS WERE REPORTED. THE DECISION WAS MADE TO REMOVE THE IMPLANTS, THE REMOVAL SURGERY WAS COMPLETED ON (B)(6) 2025 AND THE PATIENT WAS FUSED.

  Patient problems: Insufficient Information

  MAUDE report 22493816 ↗
• InjuryMar 18, 2025Migration; Migration

  A PATIENT WAS IMPLANTED WITH A PDC VIVO IMPLANT AT LEVEL C4-5 ON (B)(6) 2024. THE PATIENT HAD A FOLLOW UP APPOINTMENT WHERE X-RAYS REVEALED DETERIORATING BONE BELOW THE IMPLANT. AT THAT TIME, THE PATIENT HAD NO PAIN. THE PATIENT RECENTLY DEVELOPED PAIN AND ADDITIONAL X-RAYS REVEALED MORE DETERIORATION OF BONE BELOW THE IMPLANT. IT IS UNCERTAIN WHAT CAUSED THE BONE DETERIORATION. THE SURGEON REMOVED THE IMPLANT AND FUSED THE LEVEL ON (B)(6) 2025. THE PATIENT HAD NO ISSUES DURING THE REMOVAL SURGERY AND IS DOING WELL NOW.

  Patient problems: Neck Pain; Osteolysis

  MAUDE report 21633302 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A PRODISC C VIVO DEVICE AT C5-6 ON (B)(6) 2025. PATIENT WAS EXPERIENCING ONGOING PAIN AND AN MRI WAS ORDERED. MRI SHOWED A POSSIBLE HEMATOMA OF UNKNOWN ORIGIN; THE SURGEON WAS UNCERTAIN ABOUT THE HEMATOMA DUE TO DEVICE ARTIFACT ON THE MRI. SURGEON REMOVED THE IMPLANT ON (B)(6) 2025 AND REPLACED IT WITH A KEELED IMPLANT.

  Patient problems: Limb Pain

  MAUDE report 21510209 ↗
• InjuryAug 28, 2024Migration; Migration

  A PATIENT WAS IMPLANTED WITH A PRODISC C VIVO IMPLANT AT C5-6 ON (B)(6) 2023. PATIENT WAS EXPERIENCING NECK PAIN AND INSTABILITY AND IT WAS FOUND THAT THE IMPLANT HAD MIGRATED POSTERIORLY. THE IMPLANT WAS REMOVED ON (B)(6) 2024 AND THE PATIENT WAS FUSED.

  Patient problems: Neck Pain

  MAUDE report 20085662 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH TWO PDC VIVO IMPLANTS AT C5-6 AND C6-7 ON (B)(6) 2024. THE PATIENT HAD ONGOING RADICULOPATHY. A ONE LEVEL PDC VIVO REMOVAL WAS COMPLETED ON (B)(6) 2024. PATIENT WAS CONVERTED TO A CAGE AND PLATE SYSTEM. NO DEVICE ISSUES WERE SEEN.

  Patient problems: Pain

  MAUDE report 20042435 ↗
• InjuryJun 7, 2024Osseointegration Problem; Osseointegration Problem

  A PATIENT RECEIVED A PRODISC C VIVO IMPLANT AT LEVEL C5-6 ON (B)(6) 2023. IT WAS FOUND THAT THE IMPLANT HAD SUBSIDED. A REMOVAL WAS COMPLETED ON (B)(6) 2024 AND THE PATIENT WAS CONVERTED TO FUSION.

  Patient problems: Insufficient Information

  MAUDE report 19483280 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT ORIGINALLY HAD A 2-LEVEL PDC VIVO IMPLANTED ON (B)(6) 2022 AT C5/6 AND C6/7. THE PATIENT DID FINE FOR A LONG PERIOD OF TIME. AT SOME POINT, HE WAS HIT BY LIGHTNING, AND THAT IS WHEN HE STARTED TO HAVE PAIN. IN ADDITION TO THE LIGHTNING STRIKE, HE ALSO HAS A FAILED CARPAL TUNNEL SURGERY SO HE HAD PAIN IN HIS HAND. ALTHOUGH THE PATIENT'S IMPLANTS APPEARED TO BE IN GOOD POSITION AND DID NOT MIGRATE, HE DID HAVE EXCESSIVE BONE GROWTH ANTERIOR TO THE IMPLANT, WHICH APPEARED TO LIMIT MOTION. SINCE THE PATIENT HAD PAIN IN HIS HAND WHICH MAY OR MAY NOT HAVE BEEN GENERATED BY THE IMPLANT AT C5/6, THE SURGEON DECIDED TO REMOVE THE VIVO IMPLANT AT C5/6 AND TO FUSE THAT SEGMENT, WHILE LEAVING THE VIVO IMPLANT AT C6/7 INTACT AND IN PLACE. ADDITIONALLY, THE PATIENT HAD PAIN COMING FOR C4/5 SO THAT LEVEL WAS FUSED AS WELL. THE REVISION SURGERY TOOK PLACE ON (B)(6) 2024 AND RESULTED IN A 2-LEVEL FUSION AT C4/5/6 ABOVE A VIVO IMPLANT AT C6/7 WHICH WAS LEFT INTACT.

  Patient problems: Extraskeletal ossification; Limb Pain

  MAUDE report 19231589 ↗
• InjuryMar 7, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A PATIENT WAS IMPLANTED WITH TWO PRODISC C VIVO IMPLANTS ON (B)(6) 2023. PATIENT EXPERIENCED A BURNING SENSATION AND PAIN. IT WAS DETERMINED THAT THE PATIENT HAD A NICKEL ALLERGY. THE IMPLANTS WERE REMOVED ON (B)(6) 2024 AND REPLACED WITH SIMPLIFY CTDR. IT WAS FOUND AFTER REMOVAL THAT A DEVICE CULTURE DETERMINED THE PRESENCE OF AN INFECTION.

  Patient problems: Burning Sensation; Hypersensitivity/Allergic reaction; Pain; Unspecified Infection

  MAUDE report 18860775 ↗
• InjuryJun 21, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A PATIENT WAS IMPLANTED WITH A PRODISC C VIVO DEVICE AT LEVEL C6-7 ON (B)(6) 2023. THE IMPLANT WAS REMOVED ON (B)(6) 2023. THE PATIENT WAS COMPLAINING ABOUT PAIN IN BOTH ARMS; WITH THE RIGHT ARM BEING WORSE THAN THE LEFT AS THE REASON FOR THE REMOVAL. X-RAY IMAGES WERE PROVIDED. THE SURGEON STATED THAT THE IMPLANT PLACEMENT LOOKS PERFECT, BUT INADEQUATE DECOMPRESSION MAY HAVE OCCURRED ON THE ASYMPTOMATIC SIDE.

  Patient problems: Pain

  MAUDE report 17173396 ↗

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