BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MEDTRONIC TISSUE

    MDR report key: 4301316 · Received December 5, 2014

    Report

    Report Number
    1030489-2014-04671
    Event Type
    Injury
    Date Received
    December 5, 2014
    Date of Event
    August 5, 2010
    Report Date
    November 5, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    DWS
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOCATION : HOSPITAL. A LITERATURE ARTICLE BY XU, J, ET.AL TITLED ANTERIOR Z-PLATE AND TITANIC MESH FIXATION FOR ACUTE BURST THORACOLUMBAR FRACTURE IN (SPINE 2011;36:E498¿E504).

    Description of Event or Problem · 1

    IT WAS REPORTED IN A RETROSPECTIVE REVIEW OF A CONSECUTIVE SERIES OF 48 PATIENTS WITH THORACOLUMBAR BURST FRACTURE TREATED WITH ANTERIOR CORPECTOMY. PREOPERATIVE CLINICAL AND RADIOGRAPHIC DATA OF ALL CASES WERE ORIGINALLY COLLECTED. SURGICAL INDICATIONS WERE MOTOR NEUROLOGIC DEFICIT AND THORACOLUMBAR COLUMN INSTABILITY. 48 CONSECUTIVE PATIENTS WITH ACUTE THORACOLUMBAR BURST FRACTURES WHO WERE TREATED IN AN OUT UNIT WITH ANTERIOR DECOMPRESSION, TITANIC MESH AUTOGRAFT, AND INTERNAL FI XATION WITH A Z-PLATE WERE EVALUATED. THERE WERE 30 MALE AND 18 FEMALE PATIENTS IN THIS GROUP. THE MEAN AGE WAS 39.2 YEARS (RANGE, 23¿52 YEARS). THE FRACTURE LEVELS WERE 6 T11, 20 T12, 18 L1, AND 4 L2. TWENTY-TWO PATIENTS (45.8%) WITH ACUTE THORACOLUMBAR BURST FRACTURES PRESENTED WITH A NEUROLOGIC DEFICIT. THE POSTOPERATIVE RECOVERY OF NEURAL FUNCTION, RESTORATION OF ANTERIOR CORTEX COLLAPSE, KYPHOTIC ANGLE, AND SPINAL CANAL COMPROMISE WERE OBSERVED. THREE PATIENTS HAD A PROLONGED CHEST TUBE REMOVAL AND NO ONE DEVELOPED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787080 UNKNOWN MEDTRONIC TISSUE DWS MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR