ProDisc-C 09.820.036SRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705034763767), received between Jun 28, 2018 and Oct 25, 2018 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A PRODISC C REMOVAL ON (B)(6) 2018. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME REPORTED. THIS REPORT IS FOR ONE (1) PRODISC-C IMPLANT MEDIUM DEEP 6MM-STERILE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 8007350 ↗
• InjuryJul 17, 2018Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2018, THE PATIENT UNDERWENT REMOVAL OF A PRODISC CERVICAL (PRODISC-C) IMPLANT. THE PRODISC-C ARTIFICIAL DISC REPLACEMENT DEVICE WAS ORIGINALLY IMPLANTED ON (B)(6) 2018. ON AN UNKNOWN DATE, THE PATIENT REPORTEDLY FELL AND THE PRODISC-C BECAME DISLODGED. THE IMPLANT WAS EASILY REMOVED. THE SURGEON IS LEAVING THE DISC SPACE AND REVISING WITH POSTERIOR FUSION. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO ISSUES, NO REPORTED SURGICAL DELAY, AND NO HARM TO THE PATIENT. THIS REPORT IS FOR A PRODISC-C IMPLANT MEDIUM DEEP 6MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7695661 ↗
• InjuryJun 28, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORT THAT THE PATIENT HAD SURGERY ON (B)(6) 2018 FOR TREATMENT WITH A PRODISC C (PDC) ARTIFICIAL DISC REPLACEMENT AT C4-C5 SPINE DISC LEVEL. PATIENT WAS IMPLANTED WITH ONE (1) PDC MEDIUM DEEP 6MM-STERILE IMPLANT. POST-OPERATIVELY ON AN UNKNOWN DATE, DURING A ROUTINE SURGEON FOLLOW UP OFFICE VISIT, THE PATIENT PRESENTED WITH A MIGRATED IMPLANT. THE PDC IMPLANT HAD BEEN DISPLACED/MIGRATED ANTERIORLY AND WAS NOT FULLY SEATED IN THE CERVICAL DISC SPACE. ON (B)(6) 2018, THE SURGEON REMOVED THE PDC IMPLANT AND REVISED THE PATIENT TO ANOTHER, SAME SIZED PDC IMPLANT. NO FRAGMENTS WERE GENERATED DURING IMPLANT REMOVAL. IT WAS REPORTED THAT A SOFT CERVICAL COLLAR (NECK BRACE) THAT WAS USED POST-OPERATIVELY TO SUPPORT THE PATIENT'S NECK WAS IMPROPERLY FITTED. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. PATIENT IS REPORTED IN STABLE CONDITION. THIS REPORT IS FOR A PRODISC-C IMPLANT MEDIUM DEEP 6MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7647890 ↗

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