BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING HEAD SCREW

    MDR report key: 2062577 · Received April 8, 2011

    Report

    Report Number
    8030965-2011-00158
    Event Type
    Injury
    Date Received
    April 8, 2011
    Report Date
    March 17, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K000682
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MFG RECORDS HAS BEEN REQUESTED. SYNTHES IS UNABLE TO DETERMINE MFG DATE. ADD'L INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    PT IMPLANTED WITH LCP DISTAL FEMUR PLATE AND SCREWS ON (B)(6) 2011. PLATE BROKE IN SITU AND WAS REMOVED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.0MM TI LOCKING HEAD SCREW LOCKING HEAD SCREW KTT SYNTHES GMBH NA 2684210

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention PLATE