BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWIST DRILL WITH DEPTH STOP

    MDR report key: 2852087 · Received November 14, 2012

    Report

    Report Number
    1045834-2012-00049
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    September 1, 2011
    Report Date
    September 19, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBE
    PMA / PMN Number
    K080802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS WERE MADE TO HAVE DEVICE RETURNED FOR EVALUATION, HOWEVER, IT HAS NEVER BEEN RETURNED. THIS MDR WAS OPENED PER INTERNAL NOTIFICATION NUMBER (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA. INFORMATION RECEIVED INDICATED, "DEVICE WORKED PERFECTLY UNTIL THE LAST GROOVE AND SCREWS HOLDING THE DISC SEPARATED." THERE WAS NO INJURY TO THE PT. THERE WAS NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TWIST DRILL WITH DEPTH STOP HBE THE ANSPACH EFFORT, INC. E203050779

    Patients

    Seq Age Sex Outcome Treatment
    1