BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP® CONDYLAR PLATE 8 HOLES/206MM-RIGHT

    MDR report key: 3241901 · Received July 22, 2013

    Report

    Report Number
    2520274-2013-04574
    Event Type
    Injury
    Date Received
    July 22, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    K000066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES HTY AND JDW. THE INVESTIGATION COULD NOT BE COMPLETED AND A MANUFACTURING EVALUATION CAN NOT BE PERFORMED. NO CONCLUSION COULD BE DRAWN AS THE DEVICE IS NOT BEING RETURNED AND THE LOT NUMBER PROVIDED IS INCORRECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN 8 HOLE CONDYLAR PLATE BROKE DUE TO NONUNION. THE PLATE WAS REMOVED ALONG WITH 14 UNKNOWN SCREWS AND REPLACED WITH A RETROGRADE NAIL. PATIENT HAS HEALTH ISSUES WITH DIALYSIS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 15 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340300 4.5MM LCP® CONDYLAR PLATE 8 HOLES/206MM-RIGHT HRS SYNTHES (USA) 68992261

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention