BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10.5CM LONG ATTACHMENT

    MDR report key: 3042996 · Received March 7, 2013

    Report

    Report Number
    1045834-2013-00574
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    May 8, 2012
    Report Date
    May 10, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY ANSPACH. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THE DEVICE "MADE A LOUD NOISE" DURING A LUMBAR EVALUATION CASE. A DIFFERENT DRILL SYSTEM WAS BROUGHT IN TO COMPLETE THE SURGERY. NO PT OR USER INJURIES WERE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98492 10.5CM LONG ATTACHMENT HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1