BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMAL ACCESS ATTACHMENT, BLACK MAX

    MDR report key: 3063408 · Received April 11, 2013

    Report

    Report Number
    1045834-2013-01586
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    THE ANSPACH EFFORT, INC.
    Product Code
    HBE
    PMA / PMN Number
    K042783
    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 INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    REPORT 1 OF 3. REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE "BROKE WHEN USING THE BEARING SLEEVE" DURING A MINIMALLY INVASIVE MICRODISKECTOMY FOR A LEFT L4 AND L5 HERNIATED NUCLEUS PULPOSUS. THERE WAS A SHORT DELAY OF ABOUT THREE MINUTES IN SURGERY. A SPARE DEVICE WAS AVAILABLE FOR USE BUT A DRILL BIT OF THE SAME LOT NUMBER BROKE AGAIN. THE REPORTER STATED THAT A DRILL BIT FROM A DIFFERENT LOST NUMBER WAS USED AND THE CASE WAS COMPLETED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154881 MINIMAL ACCESS ATTACHMENT, BLACK MAX HBE THE ANSPACH EFFORT, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR