BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW

    MDR report key: 2913914 · Received January 14, 2013

    Report

    Report Number
    2520274-2013-00286
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    October 16, 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)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH CONDYLAR PLATE AND SCREW CONSTRUCT ON (B)(6) 2012. ON AN UNKNOWN POST-OPERATIVE DATE, PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT WHICH CAUSED THE FRACTURE TO SHIFT. PATIENT RETURNED TO THE O.R. ON (B)(6) 2012 AND UNDERWENT REVISION SURGERY TO REARRANGE THE PLATE. THIS IS 2 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20539 SCREW HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention PLATE