ProDisc-C 09.820.025SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034763729), received between Mar 22, 2018 and Oct 14, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT WAS IMPLANT WITH A PRODISC C IMPLANT AT C4-5, NO INFORMATION IS KNOWN ABOUT THE IMPLANTATION. PATIENT WAS EXPERIENCING HYPERMOBILITY AND THE SURGEON REMOVED THE IMPLANT AND FUSED THE PATIENT ON (B)(6) 2024.

  Patient problems: Hyperextension

  MAUDE report 20441413 ↗
• InjuryJul 13, 2018Break; Break

  THIS REPORT IS AGAINST USER FACILITY MEDWATCH NUMBER (B)(4). THE ONLY INFORMATION CONTAINED IN THIS REPORT IS CORRECTION OR ADDITIONAL INFORMATION. IT WAS REPORTED THAT THE PATIENT HAD AN ORIGINAL SURGERY SOMETIME IN (B)(6) 2017 FOR TREATMENT WITH (PDC) PRODISC-C IMPLANT AT SPINE DISC LEVEL C6. SOMETIME IN (B)(6) 2018, THE PDC IMPLANT WAS REMOVED DUE TO DEVICE FAILURE. THE EXPLANT WAS DUE TO A FRACTURE IN THE DEVICE AT THE RIGHT SUPERIOR ENDPLATE OF C6. SURGEON REMOVED THE FRACTURED PDC IMPLANT AND RE-IMPLANTED A NEW PDC IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7686130 ↗
• InjuryApr 30, 2018Migration or Expulsion of Device; Unintended Movement; Migration or Expulsion of Device; Unintended Movement

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REMOVAL OF A PRODISC-C AT C5-C6 ON (B)(6) 2018 DUE TO ANTERIOR MIGRATION (WORKED ITS WAY OUT) AND WAS CAUSING PROBLEMS (SORE THROAT) FOR THE PATIENT. THE PATIENT WAS REVISED TO CORTICAL-CANCELLOUS ACF BONE SPACER AND AN ANTERIOR CERVICAL PLATE AND SCREWS. SURGICAL DELAY AND PATIENT OUTCOME ARE UNKNOWN. THIS REPORT IS FOR ONE (1) PRODISC-C IMPLANT MEDIUM 5 MM-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 7472265 ↗
• InjuryMar 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A SPINE SURGERY PROCEDURE ON (B)(6) 2018 WHERE THE SURGEON WAS SCHEDULED TO USE A (PDC) PRO-DISC C IMPLANT. INTER-OPERATIVE, THE PDC IMPLANT WAS UNABLE TO BE FULLY IMPLANTED DUE TO THE SURGEON HAVING ISSUES IN ACHIEVING THE ACCEPTABLE IMPLANT SPINE POSITION. THE PDC IMPLANT WAS REMOVED FROM THE DISC SPACE. PATIENT WAS ULTIMATELY REVISED TO A SPINE FUSION CONSTRUCT. HOSPITAL HAS RETAINED THE PDC IMPLANT. SURGERY WAS COMPLETED SUCCESSFULLY WITH A 20 ¿ MINUTE TIME DELAY. REASON FOR THE TIME DELAY WAS DUE TO THE SURGEON HAVING TO BREAK SCRUB TO SPEAK WITH THE PATIENT¿S FAMILY DUE TO A RISK MANAGEMENT REQUIREMENT. NO FRAGMENTS WERE GENERATED DURING THE IMPLANT REMOVAL. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. PATIENT IS REPORTED IN STABLE CONDITION, AND SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) PRODISC C IMPLANT THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7362012 ↗

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