BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN INSERTER/EXTRACTOR REPLACEMENT JAW

    MDR report key: 2063161 · Received March 22, 2011

    Report

    Report Number
    1822565-2011-00712
    Event Type
    Malfunction
    Date Received
    March 22, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 23, 2011
    Manufacturer
    ZIMMER, INC.
    Product Code
    MBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSTRUMENT CAME APART. THE JAW CLIP WAS FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXGEN INSERTER/EXTRACTOR REPLACEMENT JAW MBH ZIMMER, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1