BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECD H20-27 PEEK

    MDR report key: 3093998 · Received May 6, 2013

    Report

    Report Number
    8030965-2013-02112
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    JDN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE SURGEON USED BONE NIBBLERS TO PULL THE PLATE OUT OF T2 AND THEN TO CLOSE THE PATIENT. THIS IS REPORT 1 OF 3 FOR (B)(4). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO A DEVICE MARKETED IN THE USA. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: ON AN UNKNOWN DATE, AN EXPANDABLE CORPECTOMY DEVICE (ECD) AND VECTRA PLATE WERE IMPLANTED FOR A C7 TUMOR. THE PATIENT DEVELOPED MYELOPATHY DUE TO MALPOSITION OF THE IMPLANT. ON (B)(6) 2013, THE SURGEON PERFORMED A REVISION SURGERY TO IMPLANT A CAGE, PLATE, AND LARGER DIAMETER SCREWS. A SCAN SHOWED THE TUMOR WAS THEN ALSO IN T1. THE OPERATION WAS A CORPECTOMY, AT T1 THEN AN ECD FROM C6 TO T2 FOLLOWED BY PLATING BETWEEN THOSE TWO LEVELS. AN X-RAY TAKEN SHOWED THE CAGE WAS WRONGLY POSITIONED. THE CAGE WAS REPOSITIONED. A 75MM PLATE WAS ATTACHED AND TWO SCREWS WERE IMPLANTED. THE SURGEON NEEDED TO REMOVE THE VECTRA PLATE AS IT WAS TOO SHORT. HE ATTEMPTED TO USE THE REMOVAL INSTRUMENT BUT COULD NOT GET IT TO ENGAGE PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196789 ECD H20-27 PEEK JDN SYNTHES GMBH AA2317

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention