BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3131779 · Received May 29, 2013

    Report

    Report Number
    3003506883-2013-00239
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K000066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    A PATIENT WITH A FEMUR FRACTURE WAS IMPLANTED WITH A PLATE AND SCREW CONSTRUCT ON (B)(6) 2013. ON AN UNKNOWN DATE, IT WAS DISCOVERED THAT THE PATIENT HAD NON-UNION. THE PATIENT RETURNED TO THE OR FOR REVISION ON (B)(6) 2013. ALL HARDWARE WAS REMOVED AND THE PATIENT WAS REVISED TO A 95 DEGREE BLADE PLATE. THE IMPLANTS WILL NOT BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 11 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235524 4.5MM LCP® CONDYLAR PLATE 8 HOLES/206MM-RIGHT HRS SYNTHES ELMIRA 5511948

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention