BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PYRAMESH

    MDR report key: 4301559 · Received December 5, 2014

    Report

    Report Number
    1030489-2014-04672
    Event Type
    Injury
    Date Received
    December 5, 2014
    Date of Event
    December 15, 2010
    Report Date
    November 5, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    EZX
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). NEITHER DEVICE NOR IMAGES WERE RETURNED. A LITERATURE ARTICLE BY Z. B ET.AL TITLED, TREATMENT OF THORACOLUMBAR BURST FRACTURES BY MEANS OF ANTERIOR FUSION AND CAGE, IN (J SPINAL DISORD TECH 2012;25:30¿37).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWENTY-TWO PATIENTS THAT HAD SUSTAINED A THORACOLUMBAR BURST FRACTURE WERE INCLUDED IN THIS STUDY. ON ADMISSION, 20 PATIENTS (90.9%) HAD AN INCOMPLETE NEUROLOGICAL DEFICIT. AN ANTERIOR THORACOLUMBAR APPROACH WAS USED TO PERFORM ANTERIOR CORPECTOMY AND RECONSTRUCTION WITH A MESH CAGE AND LATERAL FIXATION WITH SCREWS AND DUAL RODS. NINETY PERCENT OF PATIENTS WERE OPERATED WITHIN 2 DAYS AFTER ADMISSION AND ALL WERE FOLLOWED FOR A MINIMUM OF 25 MONTHS. THE MEAN FOLLOW-UP PERIOD WAS 47.4 MONTHS (RANGE, 25 TO 71 MO). BLOOD LOSS AVERAGED 1445 ML. OF THE 20 PATIENTS WITH INCOMPLETE NEUROLOGICAL LESIONS, THERE WERE 6 (30%) PATIENTS WITH AN IMPROVEMENT OF AT LEAST 1 AMERICAN SPINAL INJURY ASSOCIATION GRADE. NO NEUROLOGICAL DETERIORATION WAS OBSERVED IN ANY CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787970 UNKNOWN PYRAMESH EZX MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR SCREWS, RODS