BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.0 CM LONG ATTACHMENT

    MDR report key: 3042457 · Received April 3, 2013

    Report

    Report Number
    1045834-2013-01275
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 7, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBC
    PMA / PMN Number
    K011444
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED BY ANSPACH. THE DEVICE WAS EVALUATED AND PASSED ALL MFG SPECS. THE EVENT COULD NOT BE CONFIRMED. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING THAT DURING A SPINE SURGERY THE DEVICE "WOULD NOT ALLOW THE BURR TO SPIN FREELY." A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO INJURIES OR MEDICAL INTERVENTION REPORTED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136731 11.0 CM LONG ATTACHMENT HBC THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1