Prodisc C 09.820.036SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00843193112798), received between Nov 22, 2021 and Apr 1, 2026 — classified as 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2026Migration

  A PATIENT (51 YO, FEMALE) WAS IMPLANTED WITH A PRODISC C DEVICE AT C4-5 ON (B)(6) 2025. PATIENT HAS A FRACTURE OF C5, LEFT SIDE WORSE THAN RIGHT, CAUSING SCOLIOSIS. THERE IS GROSS INSTABILITY AND MIGRATION OF THE IMPLANT SEEN UPON FLEX-EX IMAGING. C5-7 IS KYPHOTIC AND LARGE ANTERIOR OSTEOPHYTES AT C6-7. PATIENT HAS ONGOING PAIN. A REMOVAL WAS COMPLETED ON (B)(6) 2026 AND THE PATIENT WAS FUSED.

  Patient problems: Pain; Vertebral Fracture

  MAUDE report 24752752 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANTED WITH A PRODISC C DEVICE AT LEVEL C5-6 ON (B)(6) 2021. PATIENT BEGAN EXPERIENCING RADICULAR SYMPTOMS AND THE IMPLANT WAS REMOVED ON (B)(6) 2024. THE PATIENT WAS CONVERTED TO A TWO LEVEL ACDF.

  Patient problems: Pain

  MAUDE report 20076465 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A PRODISC C IMPLANT AT LEVEL C3-4 ON (B)(6) 2023. DUE TO THE PATIENT'S POOR BONE QUALITY THE SURGEON REMOVED THE PDC IMPLANT ON (B)(6) 2023 AND PERFORMED A CORPECTOMY AT THE LEVEL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18182433 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED NECK PAIN SYMPTOMS AT A 2 YEAR FOLLOW UP APPOINTMENT. THE PAIN STARTED AROUND (B)(6) 2021. THIS CASE IS A 2 LEVEL PRODISC C AT C5-6 AND C6-7 IMPLANTED ON (B)(6) 2019. X-RAYS APPEAR TO SHOW THE SUPERIOR ENDPLATE OF THE C5-6 PRODISC IMPLANT HAVE SUBSIDED INTO THE VERTEBRAL BODY AND A CONFIRMED SPLIT OF THE C5 VERTEBRAL BODY. THE SURGEON ORDERED A CT SCAN TO CONFIRM THE C5 FRACTURE. THE REPORTER PROVIDED THE SCAN AND CONFIRMED THAT C5 HAS FRACTURED. THE SPLIT IN THE MIDLINE OF THE C5 VERTEBRAL BODY IS EVIDENT ON THE CT SCAN IMAGES. THE PATIENT DID SAY SHE WAS NOT IN AN ACCIDENT AND DID NOT FALL WHEN ASKED. CT SCANS WERE PERFORMED AFTER INITIAL FOLLOW UP VISIT. NO INDICATION OF REVISION/REMOVAL SURGERY OR OTHER TREATMENT. THE C5/6 PRODISC C IMPLANT APPEARS TO BE IN LATERAL IMPINGEMENT.

  Patient problems: Neck Pain; Vertebral Fracture

  MAUDE report 12851384 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT REPORTED NECK PAIN SYMPTOMS AT A 2 YEAR FOLLOW UP APPOINTMENT. THE PAIN STARTED AROUND (B)(6) 2021. THIS CASE IS A 2 LEVEL PRODISC C AT C5-6 AND C6-7 IMPLANTED ON (B)(6) 2019. X-RAYS APPEAR TO SHOW THE SUPERIOR ENDPLATE OF THE C5-6 PRODISC IMPLANT HAVE SUBSIDED INTO THE VERTEBRAL BODY AND A CONFIRMED SPLIT OF THE C5 VERTEBRAL BODY. THE SURGEON ORDERED A CT SCAN TO CONFIRM THE C5 FRACTURE. THE REPORTER PROVIDED THE SCAN AND CONFIRMED THAT C5 HAS FRACTURED. THE SPLIT IN THE MIDLINE OF THE C5 VERTEBRAL BODY IS EVIDENT ON THE CT SCAN IMAGES. THE PATIENT DID SAY SHE WAS NOT IN AN ACCIDENT AND DID NOT FALL WHEN ASKED. CT SCANS WERE PERFORMED AFTER INITIAL FOLLOW UP VISIT. NO INDICATION OF REVISION/REMOVAL SURGERY OR OTHER TREATMENT. THE C5/6 PRODISC C IMPLANT APPEARS TO BE IN LATERAL IMPINGEMENT.

  Patient problems: Neck Pain; Vertebral Fracture

  MAUDE report 12851382 ↗

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