BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP PLATE 10 HOLES 137MM

    MDR report key: 2822540 · Received November 7, 2012

    Report

    Report Number
    3003506883-2012-00353
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 10, 2012
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH 3.5MM LCP PLATE AND SIX CORTEX SCREWS ON (B)(6) 2012, FOLLOWING AN INJURY ON (B)(6) 2012. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2012, FOR REMOVAL OF HARDWARE DUE TO NON UNION. IT WAS REPORTED THAT ONE 3.5MM CORTEX SCREW BROKE DISTALLY POST OPERATIVE. TWO 3.5MM CORTEX SCREWS PULLED OUT DISTALLY FROM THE BONE. SURGEON REMOVED ALL HARDWARE AND REVISED PATIENT TO A 10 HOLE PLATE, FOUR 3.5MM LOCKING SCREWS AND THREE 3.5MM CORTEX SCREWS PLACED MORE DISTALLY. PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THIS IS 1 OF 7 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5MM LCP PLATE 10 HOLES 137MM PLATE KTT SYNTHES ELMIRA 6527741

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention SCREWS