BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SLIMLOC SCREW 14MM

    MDR report key: 1024354 · Received April 3, 2008

    Report

    Report Number
    1526439-2008-00076
    Event Type
    Injury
    Date Received
    April 3, 2008
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    KWQ
    PMA / PMN Number
    K013877
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES HAVE NOT YET BEEN RETURNED FOR EVAL. ACCORDING TO THE DOCTOR, THE PT DID SIT-UPS JUST AFTER THE SURGERY, WHICH MIGHT HAVE MADE THE GRAFTED BONE MOVE. IT WAS REPORTED THAT NOT ONLY DID THE SCREW BACKED OUT, BUT THAT THE PLATE MIGRATED AS WELL. BASED ON THIS INFO IT APPEARS THAT THE PROBLEM WAS RELATED TO PT NON-COMPLIANCE FOLLOWING SURGERY. IF THE DEVICES ARE RETURNED AN EVAL SHALL BE COMPLETED.

    Description of Event or Problem · 1

    C4-C6 INSTRUMENTATION WAS DONE WITH SLIM LOC FOR CERVICAL SPONDYLOTIC MYELOPATHY. FOLLOW UP EIGHT DAYS LATER FOUND THROUGH X-RAY THAT THE SCREWS WERE BACKED OUT. A REVISION PROCEDURE WAS PERFORMED. AS SURGICAL INTERVENTION OCCURRED AN MDR IS BEING FILED TO DOCUMENT THIS EVENT. DEVICE 2 OF 3. SEE ALSO 1526439-2008-00075, 1526439-2008-00077.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLIMLOC SCREW 14MM CERVICAL FIXATION DEVICE KWQ DEPUY SPINE, INC. NA J341917

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention