BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.0MM TI MATRIX POLYAXIAL SCREW 20MM THREAD LENGTH

    MDR report key: 2841809 · Received November 21, 2012

    Report

    Report Number
    2530088-2012-01021
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 26, 2012
    Report Date
    October 26, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K100952
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PART OR LOT NUMBER OF DEVICE PROVIDED, THEREFORE NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. DEVICE NOT BEING RETURNED FOR EVALUATION, NO FURTHER EVALUATION CAN BE PERFORMED. DEVICE MANUFACTURE DATE NOT ABLE TO BE DETERMINED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    SURGEON INSERTED MATRIX POLYAXIAL PEDICAL SCREWS IN A 4-LEVEL THORACIC CONSTRUCT FOR FRACTURE STABILIZATION. WITHIN HOURS OF THE INITIAL SURGERY, THE PATIENT COMPLAINED SHE DID NOT HAVE FEELING IN HER LEGS AND THE SURGEON DECIDED TO REMOVE THE SCREWS IMMEDIATELY. FIVE OF THE CAPS WERE REMOVED EASILY WITH RECOMMENDED TECHNIQUES BUT THREE WERE VERY DIFFICULT TO REMOVE, STRIPPED, AND THE CAPS HAD TO BE CUT OFF SO THE PEDICLE SCREWS COULD BE REMOVED. SURGEON REPLACED ALL PEDICLE SCREWS, CAPS AND RODS PART NUMBERS UNKNOWN AND RE-DIRECTED THE TRAJECTORY OF THE SCREWS. PATIENT WAS REPORTEDLY RECOVERING WITHOUT ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.0MM TI MATRIX POLYAXIAL SCREW 20MM THREAD LENGTH SPINAL PEDICLE FIXATION NKB SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LOCKING CAPS, SCREWS, RODS