NA 332.353Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982192745), received between Mar 26, 2020 and Mar 26, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionMar 26, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2020, IT WAS NOTICED THAT BOTH SCREWS IN THE TWO (2) INSERTER/EXTRACTOR FOR CHILD HIP PLATE WERE BOUND OR CROSS-THREADED MAKING THEM UNUSABLE. THE SALES CONSULTANT ATTEMPTED TO UNSCREW THE ONE IN THE INFANT INSERTER/EXTRACTOR, BUT THE SCREW HEAD SNAPPED OFF. THIS DID NOT IMPACT A SURGERY, AS THE SALES CONSULTANT WAS CHECKING THE SET BEFOREHAND. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) INSERTER/EXTRACTOR FOR CHILD & ADOLESCENT OSTEOTOMY PLATES. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9882469 ↗