BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH VARIABLE ANGLE SCREW

    MDR report key: 88516 · Received April 30, 1997

    Report

    Report Number
    88516
    Event Type
    Injury
    Date Received
    April 30, 1997
    Date of Event
    March 19, 1997
    Report Date
    April 17, 1997
    Manufacturer
    SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD TSRH SPINAL FIXATION OF L4 = S1 ON 120296. PT HAD TO RETURN TO SURGERY ON 03/17/97 TO REPLACE 2 SCREWS THAT HAD BEEN IMPLANTED DURING THE PREVIOUS PROCEDURE THAT HAD BROKEN AT SOME POINT IN TIME AFTER THE PT WAS DISCHARGED. PER PHYSICIAN "75 MM VARIABLE ANGLE TS2M SCREWS AT SACRUM BROKE 2 DEGREES TO PATIENT'S WEIGHTS AND L5S, INSTABILITY. THE BROKEN SCREWS WERE REMOVED AND REPLACED WITH 2 SCREWS IN SACRUM ON OTHER SIDE (1-8.5 MM AND 1-7.5 MM SCREWS). PER DR. WHO PERFORMED SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH VARIABLE ANGLE SCREW Implant SPINAL FUSION IMPLANT KWP SOFAMOR DANEK * 88579

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R