BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.5MM VARIABLE ANGLE SCREW, L=35MM

    MDR report key: 139318 · Received December 19, 1997

    Report

    Report Number
    1030489-1997-00183
    Event Type
    Injury
    Date Received
    December 19, 1997
    Date of Event
    October 10, 1995
    Report Date
    November 20, 1997
    Manufacturer
    SOFAMOR DANEK MEDICAL, INC.
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SPINAL FUSION PROCEDURE ON 8/1/94. ON 10/10/95 PT UNDERWENT REVISION SURGERY TO REMOVE BROKEN RIGHT S1 SCREW. INSTRUMENTATION WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6.5MM VARIABLE ANGLE SCREW, L=35MM Implant BONE SCREW KWP SOFAMOR DANEK MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention