BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.5MM X 45MM S-LOK POLYAXIAL SCREW

    MDR report key: 3258841 · Received July 30, 2013

    Report

    Report Number
    3005739886-2013-00022
    Event Type
    Injury
    Date Received
    July 30, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 1, 2013
    Manufacturer
    SPINAL USA, INC
    Product Code
    MNI
    PMA / PMN Number
    K071438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT REPORTED INCLUDES TWO (2) FRACTURED SCREWS FROM THE SAME PART/LOT. AS BOTH SCREWS ARE FROM THE SAME PART/LOT ONLY ONE REPORT IS BEING FILED. EVAL IN PROGRESS. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT LUMBAR FUSION OF L2-L5 ON (B)(6) 2011, IN THE DOMINICAN REPUBLIC. IN (B)(6) 2013, THE PT PRESENTED WITH LOWER BACK PAIN AND A CAT SCAN TAKEN ON (B)(6) 2013, IDENTIFIED A BROKEN SCREW IN EACH OF THE L3 AND L4 PEDICLES. REVISION WAS PERFORMED ON (B)(6) 2013, DURING WHICH THE PROXIMAL PORTION OF THE FRACTURED SCREWS WERE REMOVED. INFORMATION PROVIDED BY THE SALES REP INDICATES ONLY PARTIAL FUSION WAS ACHIEVED. NO TRAUMA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355629 5.5MM X 45MM S-LOK POLYAXIAL SCREW PEDICLE SCREW SPINAL SYSTEM MNI SPINAL USA, INC NA 3458TS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R