BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.6CM TAPERED ATTACHMENT, BLACK MAX

    MDR report key: 2871927 · Received December 11, 2012

    Report

    Report Number
    1045834-2012-00087
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 15, 2012
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HSZ
    PMA / PMN Number
    K955084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED BY ANSPACH. IF ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE US STATING THAT THE "ATTACHMENT WAS EXTREMELY HOT AND SMOKING." THE DEVICE WAS USED IN A "LAMINECTOMY BILATERAL FORAMENOTOMIES" PROCEDURE. THERE WERE NO DELAYS TO THE PROCEDURE. THERE WAS NO ADDITIONAL INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12.6CM TAPERED ATTACHMENT, BLACK MAX HSZ THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1