BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS SPINE PEDICLE SCREW SYSTEM

    MDR report key: 4185719 · Received October 20, 2014

    Report

    Report Number
    3003855635-2014-00002
    Event Type
    Injury
    Date Received
    October 20, 2014
    Date of Event
    September 23, 2014
    Report Date
    October 20, 2014
    Manufacturer
    ATLAS SPINE, INC.
    Product Code
    MNI
    PMA / PMN Number
    K072426
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RECEIVED TELEPHONE CALL FROM REPRESENTATIVE INDICATING THAT THERE WAS AN ISSUE DURING A REVISION WITH PREVIOUS FUSION AT L2/L3 OF A COMPETITORS PRODUCT. HARDWARE REMOVAL WENT FINE AND WITHOUT ISSUE. SURGEON FAILED TO TAP AFTER SCREW REMOVAL. SURGICAL TECHNIQUE SPECIFICALLY ADVISES TO ALWAYS TAP TO SIZE ON REVISION SURGERIES. IMPLANT WAS INSERTED TO APPROXIMATELY 2/3 DEPTH WHEN MULTIPLE SCREWDRIVER TIP FRACTURES OCCURRED. SURGEON THEN USED A DIAMOND CUTTING WHEEL TO CUT THE EXPOSED PORTION OF THE SCREW WITH IRRIGATION AND THEN WENT DOWN ONE LEVEL. OVERALL CASE DELAY APPROXIMATELY 30 MINUTES. NO INJURY TO THE PATIENT DURING THE SURGERY. REP FOLLOWED UP WITH THE SURGEON 2 WEEKS POST OP AND SURGEON REPORTED THE PATIENT WAS RECOVERING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665299 ATLAS SPINE PEDICLE SCREW SYSTEM PEDICLE SCREW SPINAL SYSTEM MNI ATLAS SPINE, INC. 70175-001 00800, 00976, 03829

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention