BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP CURVED CONDYLAR PLATE 12 HOLES/278MM-RIGHT

    MDR report key: 3162265 · Received June 11, 2013

    Report

    Report Number
    3003506883-2013-00235
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K041911
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 4.5MM LCP CURVED CONDYLAR PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO SCRAP, NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS AT TIME OF ACCEPTANCE. NO NONCONFORMING REPORTS WERE NOTED. THE RAW MATERIAL MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH 4.5MM LCP CURVED CONDYLAR PLATE, SCREWS AND CABLES CONSTRUCT ON AN UNKNOWN DATE. PATIENT DEVELOPED AN INFECTION. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 6 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262101 4.5MM LCP CURVED CONDYLAR PLATE 12 HOLES/278MM-RIGHT KTT SYNTHES ELMIRA 6237701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention