BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PYRAMESH® IMPLANT SYSTEM

    MDR report key: 3941904 · Received July 17, 2014

    Report

    Report Number
    1030489-2014-03256
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    EZX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DYSPHAGIA. NEUROLOGICAL DEFICIT/DYSFUNCTION. MIGRATION OF DEVICE OR DEVICE COMPONENT. THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG # 905-103 AND 510K # K890601 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ANTERIOR CERVICAL SPINAL FUSION AND CORPECTOMY AT C4, C5 AND C6. ON AN UNSPECIFIED DATE POST-OPERATIVELY, IT WAS FOUND THAT THE ROUND TITANIUM MESH IMPLANT "MOVED FRONTAL". PATIENT ALSO REPORTEDLY DEVELOPED DYSPHAGIA AND NEUROLOGICAL SYMPTOMS AND THE PATIENT WAS PRESCRIBED A CERVICAL COLLAR. A REVISION SURGERY WAS PERFORMED AND ACCORDING TO THE REPORT, THE IMPLANT "WAS REPLACED WITH A NEW ONE". AFTER THE REVISION SURGERY, THE PATIENT WAS PRESCRIBED A HALO VEST. NO INFORMATION REGARDING HEALTH INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418577 PYRAMESH® IMPLANT SYSTEM MESH, METAL EZX MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention CERVICAL PLATE, 3.5X13MM SCREWS