BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2944862 · Received February 5, 2013

    Report

    Report Number
    2520274-2013-00773
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    December 14, 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. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH TWO CERVIOS CHRONOS CAGES, ONE VECTRA PLATE, AND SCREW CONSTRUCT ON AN UNKNOWN DATE. ON (B)(6) 2012 SURGEON WAS PERFORMING A REVISION SURGERY DUE TO LIQUORFISTULA ON LEVEL ONE AND NOTICED THAT A CAGE FROM THE INITIAL IMPLANT WAS CRACKED. SURGEON EXPLANTED ALL HARDWARE AT THIS TIME AND REVISED PATIENT WITH TWO SYNCAGES C AND VECTRA PLATE. THIS IS 3 OF 4 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49358 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention