BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMIS BROACH HANDLE

    MDR report key: 3121749 · Received May 8, 2013

    Report

    Report Number
    3006639916-2013-00049
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MEDACTA INTL SA
    Product Code
    LZO
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    IT
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE MOBILE PEG BROKE OFF DURING SURGERY. WE HAVE BEEN INFORMED ON (B)(6) 2013. REF # 3005180920-2013-00049.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201615 AMIS BROACH HANDLE REUSABLE SURGICAL INSTRUMENTS FOR HIP LZO MEDACTA INTL SA 095779

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK