BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP® MEDIAL DISTAL HUMERUS PLATE 7 HOLES-LEFT

    MDR report key: 2913427 · Received January 14, 2013

    Report

    Report Number
    8030965-2013-00133
    Event Type
    Injury
    Date Received
    January 14, 2013
    Report Date
    December 17, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K033995
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    PATIENT IMPLANTED WITH ORIF OF ELBOW ON (B)(6) 2012. ON UNKNOWN DATE, PATIENT FELL AND CAUSED IMPLANT TO BREAK THROUGH THE SKIN AND SOME OF THE SCREWS BACKED OUT. IT IS UNKNOWN WHICH OF THE SCREWS OR HOW MANY BACKED OUT. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2012 FOR REMOVAL OF ALL HARDWARE. PATIENT WAS REVISED WITH VARIABLE ANGLE LOCKING PLATES. THIS IS 1 OF 15 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20914 3.5MM LCP® MEDIAL DISTAL HUMERUS PLATE 7 HOLES-LEFT PLATE KTT SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention PLATE, SCREWS