BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP 4.5/5 BROAD CURV 12HO L229 SST

    MDR report key: 2842700 · Received November 21, 2012

    Report

    Report Number
    8030965-2012-01321
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 26, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K041911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    DEVICE USED AS TREATMENT. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: DURING A PERIPROSTHETIC FRACTURE PROCEDURE THE SURGEON COULD NOT SCREW INTO THE PLATE WITH THE FOLLOWING: DRILL GUIDE, LOCKING SCREW AND CERCLAGE. SURGEON DID IMPLANT THE PLATE USING CORTEX SCREWS AND COMPLETED THE PROCEDURE. THIS IS 1 OF 4 REPORTS FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LCP 4.5/5 BROAD CURV 12HO L229 SST LCP 4.5/5 BROAD CURV KTT SYNTHES GMBH 8088834

    Patients

    Seq Age Sex Outcome Treatment
    1 DRILL GUIDE, LOCKING SCREW, AND CERCLAGE.