BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACROMED VSP SCREW

    MDR report key: 185932 · Received September 1, 1998

    Report

    Report Number
    1526439-1998-00015
    Event Type
    Injury
    Date Received
    September 1, 1998
    Date of Event
    September 1, 1997
    Report Date
    September 1, 1998
    Manufacturer
    ACROMED CORP
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    SURGERY FOR DECOMPRESSION AND FUSION OF L5-S1 WAS PERFORMED ON JUNE 10, 1996 IN WHICH SINGLE LEVEL PLATES AND PEDICLE SCREWS WERE IMPLANTED. AT THE SAME TIME, ANTERIOR LUMBAR INTERBODY FUSION OF L5-S1 WAS ALSO PERFORMED. IN FEBRUARY OF 1997 THE PT COMPLAINED OF PAIN AT THE SURGERY'S SITE. IN SEPTEMBER OF 1997 A SECOND SURGERY WAS PERFORMED IN WHICH THE INSTRUMENTATION WAS EXPLANTED. AT THE TIME OF THIS SURGERY, IT WAS NOTED THAT ONE OF THE PEDICLE SCREWS HAD BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACROMED VSP SCREW Implant INTERNAL FIXATION JDN ACROMED CORP NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention