BEUDAMED
    FDA Adverse Event Injury Summary report: N

    X-PL-2.4/2.7 VA LOCK SM 27*18 TAN

    MDR report key: 2907263 · Received January 10, 2013

    Report

    Report Number
    8030965-2013-00106
    Event Type
    Injury
    Date Received
    January 10, 2013
    Report Date
    December 12, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K100776
    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 REPORTED DATE OF IMPLANT WAS (B)(6) (APPROX. (B)(6) 2012). THE REPORTED DATE OF EXPLANT WAS THREE MONTHS POST-OPERATIVE (APPROX. (B)(6) 2012). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH PLATES AND SCREWS ON AN UNKNOWN DATE IN (B)(6) FOR ARTHRODESIS MFK 1 - 2 - 3. X-RAYS TAKEN ON AN UNKNOWN DATE SHOWED NO CONSOLIDATION, NON-UNION. PATIENT WAS RETURNED TO THE OPERATING ROOM ON AN UNKNOWN DATE THREE MONTHS POST-OPERATIVE FOR REMOVAL DUE TO PSEUDARTHROSIS AND IMPLANT FAILURE. REPORTEDLY SEVERAL SCREWS WERE BROKEN. THIS IS 4 OF 5 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15209 X-PL-2.4/2.7 VA LOCK SM 27*18 TAN TI VA-LOCKING X-PLATE HRS SYNTHES GMBH 7589988

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATES, SCREWS