BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM VARIABLE ANGLE SCREW, L=40MM

    MDR report key: 139285 · Received December 19, 1997

    Report

    Report Number
    1030489-1997-00198
    Event Type
    Injury
    Date Received
    December 19, 1997
    Date of Event
    July 6, 1995
    Report Date
    November 21, 1997
    Manufacturer
    SOFAMOR DANEK MEDICAL, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SPINAL FIXATION PROCEDURE ON 10/5/94. ON 7/6/95 SHE HAD INSTRUMENTATION REMOVED. IT WAS NOTED POST-OPERATIVELY THAT SHE HAD PALPABLE HARDWARE. IT WAS FELT THAT THIS WOULD CAUSE SKIN ABRASION OR POSSIBLE TEAR. PT ELECTED TO HAVE HARDWARE REMOVED ELECTIVELY RATHER THAN WAIT UNTIL EMERGENCY REMOVAL WAS NECESSARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5MM VARIABLE ANGLE SCREW, L=40MM Implant BONE SCREW KWP SOFAMOR DANEK MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention