BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LCP RECONSTRUCTION PLATE 7 HOLES/98MM

    MDR report key: 2211420 · Received August 9, 2011

    Report

    Report Number
    8030965-2011-00538
    Event Type
    Injury
    Date Received
    August 9, 2011
    Report Date
    July 15, 2011
    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

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Description of Event or Problem · 1

    PT IMPLANTED WITH LCP RECONSTRUCTION PLATE ON (B)(6) 2011. BONE FRACTURE WAS TREATED WITH PLATE BRIDGING. FOLLOW UP VISIT SHOWED A BROKEN PATE. REPORTEDLY, PT WAS PLAYING TENNIS WHEN THE IMPLANT BROKE. PLATE WAS REMOVED ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM TI LCP RECONSTRUCTION PLATE 7 HOLES/98MM LCP RECONSTRUCTION PLATE KTT SYNTHES GMBH 3591501

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention