ProDisc-C 09.820.046SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034763798), received between Sep 5, 2018 and Mar 30, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Migration

  A PATIENT (42YO, FEMALE) WAS IMPLANTED WITH A PDC DEVICE ON (B)(6) 2019. THE PATIENT DEVELOPED MYELOPATHY AND IT WAS FOUND THAT THE IMPLANT HAD MIGRATED AND PATIENT WAS EXPERIENCING OSTEOLYSIS. THE IMPLANT WAS REMOVED ON (B)(6) 2026. THE REMOVAL SURGEON DOES NOT BELIEVE THE MYELOPATHY IS CAUSED BY THE DEVICE.

  Patient problems: Osteolysis

  MAUDE report 24708858 ↗
• InjuryMay 8, 2025Migration; Migration

  A PATIENT WAS IMPLANTED WITH TWO PRODISC C IMPLANTS ON (B)(6) 2020. PATIENT BEGAN TO COMPLAINT OF ARM PAIN AND IT WAS FOUND THAT THE ONE IMPLANT HAD SHIFTED POSTERIOR. THE IMPLANT WAS REMOVED ON (B)(6) 2025 AND THE SURGEON IMPLANTED A FIBULAR STRUT WITH FOUR HOLE PLATE.

  Patient problems: Limb Pain

  MAUDE report 21984886 ↗
• InjuryJul 1, 2019Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REMOVAL OF A PRODISC-C IMPLANT DUE TO PAIN AND AN INFERIOR ENDPLATE MIGRATION WAS OBSERVED. INITIALLY, THE PATIENT HAD IMPLANTATION ON (B)(6) 2018. HOWEVER, THE PDC BALL AND SOCKET WAS DISLODGED AND NO LONGER IN CONTACT. THUS, THE PDC WAS REPLACED WITH A CENTINEL ANTERIOR PLATE AND INTERBODY CAGE. THE PATIENT HAD FACET PAIN THAT WAS INJECTED TWICE (2X) PRIOR TO THE PDC REMOVAL. THE PATIENT HAD HETEROTOPIC OSSIFICATION AT THE PDC LEVEL AND ALSO HAD PRIOR FUSION AT C 5-6 AND C 6-7 USING AN ROI-C (LDR) DEVICE. THE PATIENT'S BONE QUALITY WAS GOOD. AN EXPLANTED DEVICE WAS SUCCESSFULLY RETRIEVED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY REPORTED. PATIENT OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) PRODISC-C IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Calcium Deposits/Calcification; Pain

  MAUDE report 8748256 ↗
• InjurySep 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT A PRODISC-C HARDWARE REMOVAL DUE TO ADJACENT LEVEL DISEASE. THE SURGEON SUCCESSFULLY REMOVED THE PRODISC-C DEVICE AND THE PATIENT WAS REVISED TO ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) 2 LEVEL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED SURGICAL DELAY. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. THE PATIENT WAS STABLE AFTER THE PROCEDURE. THIS REPORT IS FOR A PRODISC-C IMPLANT LARGE 6MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7848033 ↗

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