BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM SINGLE INNIE SETSCREW

    MDR report key: 1153081 · Received September 8, 2008

    Report

    Report Number
    1526439-2008-00160
    Event Type
    Injury
    Date Received
    September 8, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    KWP
    PMA / PMN Number
    K062174
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TORQUE WRENCH WAS RETURNED FOR EVAL. TESTING CONFIRMED THAT THE DEVICE IS FUNCTIONING WITHIN SPEC. THE LOOSENING OF THE SETSCREW DOES NOT APPEAR TO HAVE BEEN RELATED TO THE TORQUE HANDLE USED IN THE CASE. A DEFINITIVE CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. CARE MUST BE TAKEN TO ENSURE THAT THE CONSTRUCT FULLY TIGHTENED AND ASSEMBLED PROPERLY. CONSTRUCT LOOSENING IS LISTED AS A POSSIBLE ADVERSE OUTCOME IN THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE.

    Description of Event or Problem · 1

    IT WAS NOTED DURING POST-OP VISIT THAT THE LEFT L1 SETSCREW WAS DISLODGED. PT REQUIRED FURTHER SURGERY TO REPLACE THE SETSCREW. PT WAS REPORTED TO BE OBESE IMPLANTED WITH HARDWARE FROM L1-S1. AS SURGICAL INTERVENTION OCCURRED AN MDR IS BEING FILED TO DOCUMENT THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM SINGLE INNIE SETSCREW FIXATION DEVICE KWP DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention