BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VA-LCP PROX-TIB-PL3.5 LARGE BEND R 4HO L

    MDR report key: 2944864 · Received February 5, 2013

    Report

    Report Number
    8030965-2013-00333
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Report Date
    December 14, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K120689
    Product Problem
    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: CLINIC REPORTED ISSUE WITH PROXIMAL TIBIA PLATES NOT FITTING PROPERLY TO THE PROXIMAL TIBIA. IT IS REPORTED THAT THE CUSTOMER HAD TO BEND PLATES SLIGHTLY IN ORDER FOR THEM TO FIT BETTER. THIS IS 2 OF 6 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48230 VA-LCP PROX-TIB-PL3.5 LARGE BEND R 4HO L VA-LCP TIBIA PLATE HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1