BEUDAMED
    FDA Adverse Event Injury Summary report: N

    K2M SPINE SCREWS

    MDR report key: 17536136 · Received August 12, 2023

    Report

    Report Number
    MW5143026
    Event Type
    Injury
    Date Received
    August 12, 2023
    Date of Event
    December 19, 2012
    Report Date
    February 21, 2013
    Manufacturer
    K2M, INC. 751 MILLER DRIVE SE, LEESBURG, VIRGINIA
    Product Code
    OSH
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    EMPIRE MEDICAL; DURING A MAST LUMBAR FUSION THE SURGEON USED A MEDTRONIC NAVLOCK AWL AND TAP, AND THEN ATTEMPTED TO USE A DIFFERENT SPINE COMPANIES SCREWS (K2M). THE SCREWS WOULD NOT THREAD AFTER ATTEMPTING MULTIPLE TIMES. THEREFORE, THE SURGEON BECAME FRUSTRATED WITH THE SPINE REP (NON MEDTRONIC) AND ABORTED NAVIGATION. A C-ARM WAS BROUGHT IN AND USED THE OTHER SPINE COMPANY'S INSTRUMENTS TO SUCCESSFULLY FINISH THE SURGERY WITHOUT NAVIGATION. WE ALL AGREED THAT THE MEDTRONIC TAP WAS NOT COMPATIBLE (DIFFERENT THREADS) WITH THE SPINE COMPANY (K2M). (B)(4) . THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    941527 K2M SPINE SCREWS PEDICLE SCREW SPINAL SYSTEM, ADOLESCENT IDIOPATHIC SCOLIOSIS OSH K2M, INC. 751 MILLER DRIVE SE, LEESBURG, VIRGINIA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown