Prodisc C Vivo PDVM5Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00843193113672), received between Mar 7, 2024 and Sep 15, 2026 — classified as 17 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration” (13 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 21 most recent of 21 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 50772989 ↗
• MalfunctionMay 5, 2026Migration

  A PATIENT (44YO, FEMALE) WAS IMPLANTED WITH A PDC VIVO DEVICE IN (B)(6) 2024 AT LEVEL C3-4. AT 18 MONTHS POSTOP IT WAS FOUND THAT THE IMPLANT HAD MIGRATED.

  Patient problems: Insufficient Information

  MAUDE report 25087122 ↗
• MalfunctionApr 7, 2026Migration

  A PATIENT WAS IMPLANTED WITH A PDC VIVO DEVICE AT C4-5 ON (B)(6) 2024. AT SIX MONTHS POSTOP THE IMPLANT WAS WELL POSITIONED. AT EIGHTEEN MONTHS POSTOP THE SUPERIOR ENDPLATE HAD MIGRATED. NO PATIENT SYMPTOMS OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24802589 ↗
• MalfunctionApr 7, 2026Migration

  A PATIENT WAS IMPLANTED WITH A PDC VIVO DEVICE AT C4-5 ON (B)(6) 2024. AT EIGHTEEN MONTHS POSTOP THE SUPERIOR ENDPLATE HAD MIGRATED. NO PATIENT SYMPTOMS OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24802588 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT (33 YEAR-OLD, FEMALE) WAS IMPLANTED WITH A PDC VIVO DEVICE ON (B)(6) 2023. PATIENT HAS ONGOING PAIN AND RADICULOPATHY. SURGEON BELIEVES THAT THE PATIENT HAS AN UNDIAGNOSED AUTOIMMUNE CONDITION. THE IMPLANT WAS REMOVED AND THE PATIENT WAS FUSED WITH A PLATE AND CAGE ON (B)(6) 2026.

  Patient problems: Limb Pain

  MAUDE report 24675253 ↗
• MalfunctionMar 10, 2026Migration

  A PATIENT (53 YEAR, FEMALE) WAS IMPLANTED WITH TWO PRODISC C VIVO IMPLANTS AT LEVELS C4-5 AND C6-7 ON (B)(6) 2025. THE PATIENT WAS SYMPTOMATIC AND IT WAS FOUND THAT THE IMPLANT AT C4-5 HAD MIGRATED ANTERIORLY. THE SURGEON HAS MADE THE DECISION TO REVISE THE PATIENT HOWEVER THE REVISION SURGERY HAS NOT BEEN SCHEDULED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 24558658 ↗
• InjuryFeb 24, 2026Osseointegration Problem

  A PATIENT (46YO, FEMALE) WAS IMPLANTED WITH A PDC VIVO DEVICE ON (B)(6) 2025. THE PATIENT HAD PRE-IMPLANTATION SYMPTOMS RETURN AND IT WAS FOUND THAT THE IMPLANT HAD SUBSIDED. THE IMPLANT WAS REMOVED ON (B)(6) 2026 AND THE PATIENT WAS FUSED.

  Patient problems: Insufficient Information

  MAUDE report 24428223 ↗
• InjuryJan 30, 2026Migration

  A PATIENT (29YO, MALE) WAS IMPLANTED WITH A PRODISC C VIVO DEVICE ON (B)(6) 2025. THE PATIENT BEGAN EXPERIENCING PAIN AND IT WAS FOUND THAT THE IMPLANT HAD MIGRATED OVER THE COURSE OF SIX MONTHS. THE IMPLANT WAS REMOVED ON (B)(6) 2026.

  Patient problems: Neck Pain

  MAUDE report 24220949 ↗
• 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 23555982 ↗
• 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 23538307 ↗
• InjuryOct 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT WAS IMPLANTED WITH A PRODISC C VIVO DEVICE AT LEVEL C4-5 ON (B)(6) 2024. THE PATIENT WAS EXPERIENCING NECK PAIN AND IT WAS FOUND THAT THE PATIENT HAD AN INTEGRATION ISSUE WITH THE IMPLANT. THE SURGEON BELIEVES THAT EITHER THERE IS AN INFECTION AT THE SITE OR THAT ONE SIDE OF THE IMPLANT FUSED AND THE OTHER DID NOT. THE IMPLANT WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS FUSED WITH AN ANTERIOR ACDF AND POSTERIOR FUSION.

  Patient problems: Neck Pain

  MAUDE report 23366948 ↗
• InjuryJul 21, 2025Migration; Migration

  A PATIENT WAS IMPLANTED WITH A PRODISC C VIVO DEVICE ON (B)(6) 2025. THE PATIENT WAS EXPERIENCING NECK PAIN AND IT WAS FOUND THAT THE IMPLANT HAD MIGRATED ANTERIORLY. THE IMPLANT WAS REMOVED ON (B)(6) 2025 AND THE PATIENT WAS FUSED.

  Patient problems: Neck Pain

  MAUDE report 22553856 ↗
• InjuryJun 23, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  A PATIENT WAS IMPLANTED WITH A PDC VIVO IMPLANT ON (B)(6) 2024. THE PATIENT WAS FOUND TO HAVE HYPERLORDOSIS. THE SURGEON MADE THE DECISION TO REMOVE THE IMPLANT AND FUSE THE PATIENT WITH A PEEK CERVICAL SPACER AND PLATE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 22308501 ↗
• InjuryMar 24, 2025Migration; Migration

  A PATIENT WAS IMPLANTED WITH A PDC VIVO IMPLANT AT LEVEL C4-5 ON (B)(6) 2024. AT A CHECK UP IT WAS FOUND THAT THE IMPLANT HAD SUBSIDED AND MIGRATED ANTERIORLY. NO PATIENT SYMPTOMS WERE REPORTED. THE SURGEON PLANS TO REMOVE THE IMPLANT AND COMPLETE A POSTERIOR CERVICAL FUSION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21677872 ↗
• InjuryFeb 7, 2025Migration; Migration

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A PRODISC C VIVO DEVICE AT LEVEL C4-5 ON (B)(6) 2023. THE PATIENT WAS EXPERIENCING ENDPLATE MOVEMENT. THE IMPLANT WAS REMOVED ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 21334891 ↗
• InjuryJan 7, 2025Migration; Migration

  A PATIENT WAS IMPLANTED WITH A PRODISC C VIVO IMPLANT AT C4/5 ON (B)(6) 2024. THE PATIENT WAS EXPERIENCING RIGHT ARM PAIN AND IT WAS FOUND THAT THE IMPLANT HAD MIGRATED ANTERIORLY. IMPLANT WAS USED OFF LABEL AND WAS PLACED ON TOP OF SEVERAL FUSED LEVELS. THE IMPLANT WAS REMOVED AND THE PATIENT FUSED ON (B)(6) 2024.

  Patient problems: Limb Pain

  MAUDE report 21096328 ↗
• InjuryNov 27, 2024Migration; Migration

  PATIENT (45YO, FEMALE) WAS IMPLANTED WITH A VIVO IMPLANT AT C5-6 ON (B)(6) 2024. PATIENT HAD ONGOING PAIN AND IT WAS FOUND THAT THE IMPLANT HAD MIGRATED ANTERIORLY. SURGEON COMPLETED THE REMOVAL ON (B)(6) 2024 AND FUSED THE PATIENT.

  Patient problems: Limb Pain

  MAUDE report 20792930 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT RECEIVED A PDC VIVO IMPLANT ON 2023 AT C5-6 DUE TO SYMPTOMATIC CERVICAL DISC DISEASE. PATIENT DEVELOPED A FORAMINAL OSTEOPHYTE / SPUR AND STENOSIS. A PDC VIVO REMOVAL WAS COMPLETED ON (B)(6) 2024. DEVICE PLACEMENT WAS GOOD AND THERE WAS NO DEVICE RELATED ISSUE.

  Patient problems: Extraskeletal ossification

  MAUDE report 20046976 ↗
• InjuryApr 22, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  A PATIENT HAD A PDC VIVO IMPLANTED ON (B)(6) 2023. PATIENT HAD PERSISTENT NECK PAIN AND THE SURGEON SUSPECTED IMPLANT LOOSENING. THE IMPLANT WAS REMOVED ON (B)(6) 2024 AND THE PATIENT WAS CONVERTED TO FUSION WITH A SHORELINE ACDF.

  Patient problems: Neck Pain

  MAUDE report 19152706 ↗
• InjuryMar 7, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  A PATIENT REPORTED THAT THEY HAD A C5-6 ARTIFICIAL DISC REPLACEMENT WITH PRODISC C VIVO ON (B)(6) 2022. PATIENT IS EXPERIENCING RASHES AND WELTS ON THEIR BODY AS WELL AS PHARYNGEAL EDEMA, MUSCLE TENSION, DYSPHONIA, AND DYSPHAGIA. THEIR SYMPTOMS DEVELOPED WITHIN A FEW DAYS OF IMPLANTATION OF THE PDC VIVO DEVICE AND HAVE NOT IMPROVED SINCE. A BLOOD TEST DID CONFIRM THAT THE PATIENT HAD A NICKEL ALLERGY.

  Patient problems: Dysphagia/ Odynophagia; Hypersensitivity/Allergic reaction; Speech Disorder; Swelling/ Edema

  MAUDE report 18861310 ↗
• 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 18860946 ↗

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