ProDisc-C 09.820.055SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705034763811), received between Apr 12, 2018 and Jan 16, 2019 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2019Adverse 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 C5-C6 PRODISC ARTHROPLASTY AND WAS IMPLANTED WITH THE LARGE PRODISC-C IMPLANT; HOWEVER, WHEN THE PATIENT WOKE UP FROM ANESTHESIA, THEY EXPERIENCED QUADRA PARALYSIS. THE DEVICE WAS REMOVED THE SAME DAY, AND PATIENT WAS REVISED TO FUSION WITH A STAND-ALONE ANTERIOR DEVICE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. PATIENT OUTCOME WAS DOING BETTER AND CONTINUES TO IMPROVE. THIS REPORT IS FOR A PRODISC-C IMPLANT LARGE DEEP 5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available; Paralysis

  MAUDE report 8254164 ↗
• InjuryApr 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORT THAT THE PATIENT HAD ORIGINAL SURGERY ON UNKNOWN DATE FOR TREATMENT WITH A PRODISC-C, ARTIFICIAL DISC REPLACEMENT IMPLANT AT SPINE DISC LEVELS C5-C6. PATIENT WAS IMPLANTED WITH ONE (1) PRODISC-C IMPLANT. ON AN UNKNOWN DATE POST-OPERATIVE, PATIENT PRESENTED WITH OSTEOLYSIS AT THE POSTERIOR ASPECT OF C5 VERTEBRA. ON (B)(6) 2018, SURGEON REMOVED THE PRODISC-C IMPLANT AND REVISED THE PATIENT WITH PLATE AND A POLYETHER ETHER KETONE (PEEK) SPACER. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT IS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) PRODISC-C IMPLANT LARGE DEEP 5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7425678 ↗

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