BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL FIXATION SYSTEM

    MDR report key: 253589 · Received December 8, 1999

    Report

    Report Number
    1030489-1999-00181
    Event Type
    Injury
    Date Received
    December 8, 1999
    Date of Event
    July 16, 1993
    Report Date
    November 8, 1999
    Manufacturer
    SOFAMOR DANEK MANUFACTURING
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IMPLANT DATE: 1993. CT SCAN ON 7/16/1993 SHOWS A SCREW IN THE SPINAL CANAL. EXPLANTED SCREW IN 1993 AT WHICH TIME IT WAS NOTED THERE WAS A DURAL TEAR AND WAS REPAIRED. PT COMPLAINED OF PAIN AND OTHER SYMPTOMS. REVISION SURGERY IN 1994 AT WHICH TIME IT WAS FOUND THAT THERE WAS A "LOOSE" SCREW AND LACK OF FUSION ON THE LEFT SIDE. THE SITE WAS REPAIRED, BUT SCREW WAS LEFT IN PLACE DUE TO THE OPINION THAT PT COULD NOT TOLERATE FURTHER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TSRH SPINAL FIXATION SYSTEM Implant SPINAL FIXATION SYSTEM KWQ SOFAMOR DANEK MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention