BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE FEMORAL

    MDR report key: 2961884 · Received February 14, 2013

    Report

    Report Number
    2520274-2013-00943
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    May 21, 2012
    Report Date
    January 17, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFERENCE MFR# 2520274-2013-00944 FOR THE SECOND EVENT. IMPLANT DATE: (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.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(4) INDICATED A HOSPITAL IN THE (B)(6), REPORTED: PATIENT WAS TREATED WITH LISS FEMUR PLATE IMPLANTED IN (B)(6) 2012. THE PLATE WAS NOTED AS BROKEN ON (B)(6) 2012. PATIENT WAS RETURNED TO THE O.R, DATE UNKNOWN AND WAS TREATED WITH ORIF WITH LISS PLATE AND BONEGRAFT. BY (B)(6) 2012, THERE WAS NO CONVINCING CONSOLIDATION. PLATE FAILURE WAS NOTICED ON (B)(6) 2013. THIS FILE IS FOR THE PLATE BREAKAGE NOTICED IN (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65396 PLATE FEMORAL HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention