NA 245.876Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982170286), received between Dec 26, 2018 and Dec 26, 2018 — classified as 1 injury.

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. 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.

• InjuryDec 26, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018, THE PATIENT UNDERWENT REVISION DUE TO THE BROKEN PLATE. THE PATIENT UNDERWENT REMOVAL OF THE PLAQUE , WHICH WAS FRACTURED ON (B)(6) 2018. INITIALLY THE PATIENT HAD AN IMPLANT ON (B)(6) 2017 WITH 3.5 MM LOW PROFILE CURVE RECONSTRUCTION PLATE AND SIX (6) CORTICAL SCREWS. IT WAS UNKNOWN IF ALL THE IMPLANTED DEVICES WERE SUCCESSFULLY REMOVED. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. CONCOMITANT DEVICE: 3.5 CORTICAL SCREWS (PART UNKNOWN, LOT UNKNOWN, QUANTITY 6). THIS REPORT IS FOR ONE (1) 3.5MM LOW PROFILE CURVED RECONSTRUCTION PLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 8197670 ↗