BEUDAMED
    FDA Adverse Event Death Summary report: N

    Z-PLATE ATL SYSTEM

    MDR report key: 28917 · Received November 29, 1995

    Report

    Report Number
    28917
    Event Type
    Death
    Date Received
    November 29, 1995
    Date of Event
    August 29, 1995
    Report Date
    November 27, 1995
    Manufacturer
    SOFAMOR-DANEK
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD PREVIOUSLY UNDERGONE 6/9/94 SURGICAL REPAIR OF T10 BURST FRACTURE. THE THORACIC FUSION SURGERY INCLUDED: -T10 VERTEBRECTOMY & DECOMPRESSION, -T11 HEMIVERTEBRECTOMY WITH TRICOSTICAL ILIAC CREST STRUT GRAFTING FROM T9-T11, INTERNAL FIXATION WITH PLATE. LATER, ON 8/27/95, PT COMPLAINED OF BACK & ABDOMINAL PAIN & HEMOPTYSIS. ANGIOGRAM SHOWED LARGE PSEUDOANEURYSM IN LT LOWER CHEST, COMMUNICATING WITH AORTA, LOCATED NEXT TO SPINAL FIXATION DEVICE. THE COMMUNICATION WAS A VENT OT 4-6MM. PSEUDOANEURYSM DRAINED VIA DIASTOLIC PULSATOINS INTO AORTIC & THROUGH PULMONARY VENOUS CONNECTIONS. PT WAS TAKEN TO OR, LEFT THORACOTOMY, PT DIED IN OR AFTER FAILED RESUSCITATION ATTEMPTS. PROVISIONAL ANATOMIC DIAGNOSIS-RECENT THORACIC AORTIC LACERATION DUE TO EROSION TO AORTIC WALL FROM SCREW IN ORTHO HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 Z-PLATE ATL SYSTEM Implant Z-PLATE ATL SYSTEM JDN SOFAMOR-DANEK NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| O