BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP® CONDYLAR PLATE 6 HOLES/170MM-LEFT

    MDR report key: 3143345 · Received June 3, 2013

    Report

    Report Number
    3003506883-2013-00244
    Event Type
    Injury
    Date Received
    June 3, 2013
    Report Date
    May 6, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K000066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 4.5MM LCP CONDYLAR PLATES WERE PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS. THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS AT TIME OF ACCEPTANCE. NO NONCONFORMANCES WERE NOTED. THE RAW MATERIAL MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO NONCONFORMANCES DOCUMENTED. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT¿S INITIAL SURGERY WAS PERFORMED ON (B)(6) 2009, FOR A DISTAL FEMUR FRACTURE. DURING A FOLLOW UP VISIT SURGEON NOTED DEVELOPMENT OF A NON-UNION. PATIENT DID NOT WANT TO UNDERGO REVISION SURGERY AND A BONE STIMULATOR WAS USED AS AN ALTERNATIVE. SUBSEQUENTLY, THE PLATE BROKE AND SURGEON REMOVED A 4.5MM LCP CONDYLAR PLATE AND 9 ASSORTED SCREWS DUE TO A NON-UNION ON (B)(6) 2013. PATIENT WAS IMPLANTED WITH A LONGER CONDYLAR PLATE, SCREWS, DBX BONE GRAPH AND AN ARTICULATING DEVICE. THIS IS 1 OF 10 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245327 4.5MM LCP® CONDYLAR PLATE 6 HOLES/170MM-LEFT PLATE, FIXATION, BONE HRS SYNTHES ELMIRA 6099036

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention