BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACROMED

    MDR report key: 44782 · Received October 23, 1996

    Report

    Report Number
    44782
    Event Type
    Death
    Date Received
    October 23, 1996
    Date of Event
    July 19, 1996
    Report Date
    July 26, 1996
    Manufacturer
    ACROMED
    Product Code
    MCV
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    6/26/96-PT. HAD APPLICATION OF ANTERIOR LUMBAR PLATE USING SPINE TITANIUM ANTERIOR LOCKING PLATE. 7/2/96-1. LUMBAR DECOMPRESSION L1-L2, T12-L1 AND L2-L3 FOR PLACEMENT OF PEDICLE SCREW. POSTERIOR SPINAL FUSION L1-L3 PEDICLE SCREW FIXATION L1-L3. 7/19/96-READMITTED WITH ABDOMINAL PAIN. TAKEN TO OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACROMED Implant ISOLA PEDICLE SCREW MCV ACROMED * *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death UNK-PT WAS TRANSFERRED FROM REHAB FACILITY