BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEPUY

    MDR report key: 63561 · Received January 16, 1997

    Report

    Report Number
    63561
    Event Type
    Death
    Date Received
    January 16, 1997
    Date of Event
    December 27, 1996
    Report Date
    January 16, 1997
    Manufacturer
    DEPUY INC. SUB CORANGE
    Product Code
    MCV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT TO SURGERY, PRONE POSITION ON C-ARM TABLE WITH LAMINECTOMY PADS. MIDLINE INCISION MADE. PLACEMENT OF PEDICLE SCREWS PLACED AND TESTED WITH C-ARM. REPEAT VIEWS PERFORMED AND INFERIOR SCREW ON RIGHT WAS REMOVED AND REPLACED. BAR PLACED ON THE RIGHT AND TIGHTENED, LEFT SIDE SAME. CAGES FITTED AND FILLED WITH ALLOGRAFT. INCISION CLOSED. PT TAKEN TO PACU. ABDOMEN TENSE. BACK TO SURGERY. PRE-OP DIAGNOSIS: ILIAC VESSEL INJURY POST-OP, DIAGNOSIS: ILIAC VESSEL INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY Implant MOSS MIAMI SPINAL SYSTEM/PEDICLE SCREWS MCV DEPUY INC. SUB CORANGE 1755-17 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death 1755-74 ROD, 1755-26 INNER SCREW| 1755-27 OUTER NUT 1743-32 MESH