BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER BIOMET THORACIS

    MDR report key: 13111492 · Received December 28, 2021

    Report

    Report Number
    MW5106332
    Event Type
    Malfunction
    Date Received
    December 28, 2021
    Date of Event
    December 21, 2021
    Report Date
    December 23, 2021
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PLATE SCREW BROKE OFF INSIDE PATIENT'S CLAVICLE WHILE THE PLATE WAS BEING SCREWED IN. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000131 ZIMMER BIOMET THORACIS SCREW, FIXATION, BONE HWC BIOMET MICROFIXATION 762416 2.4 X 16MM 762416 2

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Other