BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PYRAMESH C TITANIUM MESH

    MDR report key: 2210221 · Received August 12, 2011

    Report

    Report Number
    1030489-2011-01049
    Event Type
    Injury
    Date Received
    August 12, 2011
    Report Date
    July 14, 2011
    Manufacturer
    WARSAW ORTHOPEDIC, INC.
    Product Code
    EZX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANTERIOR FIXATION PLATE AND SCREWS, IMPLANT DATE UNKNOWN. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 905-403, 510K # K011406 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PROCEDURE USING INTERBODY DEVICE, ANTERIOR FIXATION PLATE SCREWS VIA ACF. IT WAS REPORTED THAT THE PLATE HAD BEEN BACKED OUT POST OP. SINKING OF CAGE WAS OBSERVED TOO. THE REVISION SURGERY WAS PERFORMED. THE PLATE AND SCREWS WERE REMOVED, AND EXTERNAL FIXATION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PYRAMESH C TITANIUM MESH MESH, METAL EZX WARSAW ORTHOPEDIC, INC. NA W07B3764

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention