BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10.5 CM ANGLE ATTACHMENT, BLACK MAX

    MDR report key: 2982745 · Received February 25, 2013

    Report

    Report Number
    1045834-2013-00310
    Event Type
    Malfunction
    Date Received
    February 25, 2013
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HSZ
    PMA / PMN Number
    K831756
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY ANSPACH. THE DEVICE WAS REPAIRED AND RETURNED TO THE USER. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE USA STATING "DAMAGED BEARINGS." THE EVENT OCCURRED DURING AN OPERATION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79183 10.5 CM ANGLE ATTACHMENT, BLACK MAX HSZ THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1