BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2907251 · Received January 10, 2013

    Report

    Report Number
    2520274-2013-00256
    Event Type
    Injury
    Date Received
    January 10, 2013
    Report Date
    December 12, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    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). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RECEIVED FOR EVALUATION. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    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 2 OF 5 REPORTS FOR THE SAME EVENT.

    Description of Event or Problem · 1

    THIS REPORT IS FOR AN UNKNOWN SCREW. THIS IS 2 OF 5 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15085 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PLATES, SCREWS