BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP 4.5/5 BROAD 18HO L332 TI

    MDR report key: 2221541 · Received August 18, 2011

    Report

    Report Number
    8030965-2011-00553
    Event Type
    Injury
    Date Received
    August 18, 2011
    Report Date
    August 4, 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

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATES A CLINIC IN (B)(6) REPORTED: AN (B)(6) FEMALE WAS IMPLANTED ON (B)(6) 2011 WITH AN LCP PLATE AND SCREW. PT EXPERIENCED PAIN AND WAS RETURNED TO OPERATING ROOM FOR REMOVAL AND REVISION OF A BROKEN PLATE ON (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP 4.5/5 BROAD 18HO L332 TI 4.5 MM TI BROAD LCP PLATE KTT SYNTHES GMBH 2500944

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR SCREW