BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROAIRE

    MDR report key: 4910236 · Received July 10, 2015

    Report

    Report Number
    2020601-2015-00047
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    June 10, 2015
    Report Date
    July 7, 2015
    Manufacturer
    MICROAIRE SURGICAL INSTRUMENTS, LLC
    Product Code
    HWC
    PMA / PMN Number
    K042078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO INDICATION OF ITEM NOT FITTING IN DRILLED HOLE DURING SURGERY, OCCURRENCE WAS DETERMINED TO BE REPORTABLE TO THE FDA.

    Description of Event or Problem · 1

    FIXATION DEVICE WOULD NOT STAY INSERTED IN DRILLED HOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448716 MICROAIRE FIXATION DEVICE HWC MICROAIRE SURGICAL INSTRUMENTS, LLC CFD-010-0167 243370

    Patients

    Seq Age Sex Outcome Treatment
    1 Other