BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3MM CRSE DMND MTCHSTCK, 15CM

    MDR report key: 3063202 · Received April 11, 2013

    Report

    Report Number
    1045834-2013-01588
    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
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    REPORT 3 OF 3. REPORT RECEIVED FROM THE USA STATING THAT THE DEVICE "BROKE" WHEN USED WITH THE ATTACHMENT DURING A MINIMALLY INVASIVE MICRODISKECTOMY FOR A LEFT L4 AND L5 HERNIATED NUCLEUS PULPOSUS. THERE WAS A SHORT DELAY IN SURGERY OF ABOUT THREE MINUTES TO GET ANOTHER ATTACHMENT AND DRILL BIT. A DRILL BIT FROM ANOTHER BATCH WAS USED AND THE CASE WAS COMPLETED. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155031 3MM CRSE DMND MTCHSTCK, 15CM HBE THE ANSPACH EFFORT, INC. F493072484

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR