BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S-LOK POLYAXIAL SCREW

    MDR report key: 3023194 · Received February 27, 2013

    Report

    Report Number
    3005739886-2013-00007
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 28, 2013
    Manufacturer
    T AND S MACHINE SHOP, INC.
    Product Code
    MNI
    PMA / PMN Number
    K071438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING REPORTED BECAUSE THE DEVICE HAS BEEN THE SUBJECT OF A MALFUNCTION CAUSING DEATH OR SERIOUS INJURY WITHIN THE PAST TWO YEARS. INFO PROVIDED WAS REVIEWED BY A MEDICAL PROFESSIONAL AND IT WAS DETERMINED THAT THE ISSUE CURRENTLY BEING REPORTED DID NOT RESULT IN DEATH OR SERIOUS INJURY, DID NOT ADVERSELY AFFECT THE CLINICAL OUTCOME OF THE PROCEDURE OR WOULD, SHOULD IT RECUR. DEVICE EVAL IS NOT POSSIBLE AS DEVICE REMAINS IMPLANTED. INVESTIGATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF INVESTIGATION, A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED AT A FACILITY OUTSIDE OF THE UNITED STATES ON (B)(6) 2013, THE SLOT IN THE HEAD COMPONENT OF TWO OF THE S-LOK CANNULATED POLYAXIAL SCREW SPLAYED, PREVENTING THE CAP SCREW FROM BEING ASSEMBLED AS INTENDED. ONE OF THE SCREWS WAS REMOVED FROM THE PT AND REPLACED WITH ANOTHER SCREW THAT WAS READILY AVAILABLE. THE SECOND SCREW REMAINS IMPLANTED WITHOUT A CAP SCREW ASSEMBLED. THE PART AND LOT IDENTITY OF THE SCREW THAT REMAINS IN THE PT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85041 S-LOK POLYAXIAL SCREW S-LOK POLYAXIAL SCREW MNI T AND S MACHINE SHOP, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR