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NA 449.026Recalls & reported problems

Synthes GmbH · 2.0MM TI BROAD PLATE 6 HOLES/42MM · Class 2 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10887587054018), received between Mar 18, 2019 and Mar 18, 2019 — classified as 3 injuries.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem3

Patient problems

  • Unspecified Infection3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS NOTED THE REMOVAL PROCEDURE OCCURRED ON (B)(6) 2019.

    Patient problems: Unspecified Infection

    MAUDE report 8428665 ↗
  • InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS NOTED THE REMOVAL PROCEDURE OCCURRED ON (B)(6) 2019.

    Patient problems: Unspecified Infection

    MAUDE report 8428529 ↗
  • InjuryMar 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS NOTED THE REMOVAL PROCEDURE OCCURRED ON (B)(6) 2019.

    Patient problems: Unspecified Infection

    MAUDE report 8428483 ↗

Other PLATE, BONE devices

All PLATE, BONE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.