NA 332.16Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982192592), received between Jun 20, 2019 and Jun 20, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 20, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT REVISION SURGERY OF CONDYLAR PLATE BLADE DUE TO IMPLANT FAILURE. DURING REMOVAL OF THE IMPLANT, ONE OF THE INSERTER EXTRACTOR WITH ADJUSTABLE CLAMP FAILED. THE INSTRUMENT REFUSED TO LET GO OF THE PLATE ONCE REMOVED FROM THE PATIENT. THE PLATE WAS FINALLY REMOVED FROM THE REMOVAL INSTRUMENT, HOWEVER IT WAS NOT EASY AND THE CLAMP SCRATCHED THE PLATE DURING REMOVAL. ADDITIONAL INSTRUMENTS WERE USED TO REMOVE THE CLAMP FROM THE PLATE. THERE WAS NO SURGICAL DELAY REPORTED. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: CONDYL-PL 95° 12HO L204 BLADE60 SST (PART # 237.220-US, LOT # UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8715909 ↗