BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXGEN IMPACTOR/EXTRACTOR REPLACEMENT JAW

    MDR report key: 2042224 · Received February 15, 2011

    Report

    Report Number
    1822565-2011-00613
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 20, 2011
    Report Date
    February 15, 2011
    Manufacturer
    ZIMMER INC
    Product Code
    MBH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFO WAS REC'D FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE CLIP ON THE IMPACTOR JAW HAS FRACTURED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1