NA 03.820.025Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10705034731186), received between Apr 30, 2019 and Apr 30, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING THE PRODISC C ARTHROPLASTY PROCEDURE, THE PRODISC-C TRIAL IMPLANT BECAME STUCK IN THE TRIAL INSERTER. ONCE REMOVED IT WOULD NO LONGER ATTACH TO THE INSERTER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING THE TRIAL WITHOUT THE TRIAL INSERTER. THERE WAS A 15-MINUTE SURGICAL DELAY. PATIENT OUTCOME HAS NO ISSUES. CONCOMITANT DEVICE REPORTED: TRIAL IMPLANT MEDIUM-5MM (PART #: 03.820.025, LOT #: A7QA48, QUANTITY: 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8567076 ↗