BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWER BONE TAP 8.5MM

    MDR report key: 2052084 · Received April 1, 2011

    Report

    Report Number
    2052084
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 8, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC SOFAMOR DANEK INSTRUMENT
    Product Code
    HWX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PERFORMING LUMBAR THROUGH SACRAL VERTEBRA (L5-S1) TRANSFORMINAL LUMBAR INTER-BODY FUSION WITH EXTENSION TO PELVIS. BONE TAP BROKE OFF INSIDE PATIENT'S BONE WHILE TAPPING BONE. LEFT ABOUT 50 MM OF STAINLESS TAP IN PELVIS. SURGEON TRIED MULTIPLE TIMES TO REMOVE TAP WITHOUT SUCCESS.====================== MANUFACTURER RESPONSE FOR BONE TAP, POWER BONE TAP 8.5MM======================THEY WOULD LIKE THE EQUIPMENT BACK FOR TESTING, BUT WE HAVE SECURED THE ITEMS FOR NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWER BONE TAP 8.5MM BONE TAP HWX MEDTRONIC SOFAMOR DANEK INSTRUMENT 7480885 BA0511009

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR