BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOLA RODS, SCREWS

    MDR report key: 148510 · Received February 12, 1998

    Report

    Report Number
    1526439-1998-00003
    Event Type
    Injury
    Date Received
    February 12, 1998
    Date of Event
    November 6, 1992
    Report Date
    January 12, 1998
    Manufacturer
    ACROMED CORP
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    NINETEEN YEAR OLD MALE HAD SPINE SURGERY DUE TO UNSTABLE BURST FRACTURE AT L1 ON 5/24/1990. THE PT WAS IMPLANTED WITH ISOLA RODS AND SCREWS AND WAS INSTRUMENTED FROM T12-L2. THE PT HAS DEVICE EXPLANTED ON 11/6/1992 DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLA RODS, SCREWS Implant INTERNAL FIXATION JDN ACROMED CORP NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention