BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP® CONDYLAR PLATE 12 HOLES/278MM-LEFT

    MDR report key: 3133039 · Received May 29, 2013

    Report

    Report Number
    1719045-2013-01477
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    April 29, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K000066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE WAS IMPLANTED ON AN UNKNOWN DATE IN 2002. A DEVICE HISTORY REVIEW WAS PERFORMED. THERE WERE NO MRR¿S, NCR¿S, OR OTHER COMPLAINT RELATED ISSUES ASSOCIATED WITH THIS COMPLAINT. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS IMPLANTED ON AN UNKNOWN DATE IN 2002 WITH A 12-HOLE CONDYLAR PLATE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A MALUNION AND A BENT PLATE. THE SURGEON DETERMINED THAT A CORRECTIVE OSTEOTOMY TO THE DISTAL FEMUR WAS NEEDED. THE CORRECTIVE OSTEOTOMY WAS PERFORMED ON (B)(6) 2013. THE BENT PLATE AND 12 UNKNOWN SCREWS WERE REMOVED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237238 4.5MM LCP® CONDYLAR PLATE 12 HOLES/278MM-LEFT HWC SYNTHES MONUMENT 4468548

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention