BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERNAL FIXATION DEVICE

    MDR report key: 35223 · Received July 12, 1996

    Report

    Report Number
    35223
    Event Type
    Injury
    Date Received
    July 12, 1996
    Date of Event
    February 22, 1996
    Report Date
    March 15, 1996
    Manufacturer
    ACROMED CORP.
    Product Code
    JDN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 12/12/95, PT UNDERWENT A DECOMPRESSIVE LAMINECTOMY OF L-5; POSTERIOR LUMBAR INTERBODY FUSION WTH CANCELLOUS GRAFT OF L5-S1; VARIABLE SPINE PLATING INTERANAL FIXATION OF L-4 TO S-1; POSTEROLATERAL FUSION WITH AUTOGRAFT AND HARVERSTING OF GRAFT FROM THE RIGHT POSTERIOR ILIAC CREST AND BICORTICAL ALLOGRAFT. ABOUT 2/22/96, PT SNEEZED, FELT A SNAP IN HIS BACK, AND HAD THE INSET OF RADICULAR LEFT BUTTOCKS AND THIGH PAIN. DURING SURGERY ON 3/7/96, BOTH SACRAL SCREWS WERE FOUND TO BE LOOSE. THE L-4 SCREWS WERE REMOVED FOUND TO BE LOOSE. THE L-4 SCREWS WERE REMOVED IDENTIFYING THAT THE TOPS OF BOTH OF THESE TITANIUM VSP SCREWS HAD BEEN SHEARED OFF RIGHT AT THE NUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERNAL FIXATION DEVICE Implant INTERNAL FIXATION DEVICE JDN ACROMED CORP. SACRAL CUSTOM NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention WASHER TAPER 2225-15 X1, PSA 1727 CONES X 2, PLATE