BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP 3.5 12HO L163 TI

    MDR report key: 3240020 · Received July 22, 2013

    Report

    Report Number
    8030965-2013-04437
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    July 5, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000684
    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. INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: A PLATE BROKE POST OPERATION. ITEM 423.621, LOT 2760864 WAS IMPLANTED ON (B)(6) 2013. THE PLATE BROKE DURING THE FIRST PHASE OF BONE CONSOLIDATION. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339651 LCP 3.5 12HO L163 TI KTT SYNTHES GMBH 2760864

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention