BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NI

    MDR report key: 2911586 · Received April 11, 2008

    Report

    Report Number
    2520274-2008-00027
    Event Type
    Malfunction
    Date Received
    April 11, 2008
    Date of Event
    September 9, 2005
    Report Date
    March 20, 2008
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    PMA / PMN Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO INVESTIGATION COULD BE PERFORMED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED.

    Description of Event or Problem · 1

    PATIENT DIAGNOSED WITH 20 DEGREES VALGUS DEFORMITY WITH OSTEOARTHRITIS IN KNEE, UNDERWENT 16 DEGREES CLOSING WEDGE MEDIAL OSTEOTOMY LEFT DISTAL FEMUR. FOLLOW-UP X-RAY SHOWED PLATE HAD BROKEN. DURING REVISION PROCEDURE BROKEN PLATE WAS REMOVED AND THE SURGEON FOUND 2 SCREWS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NI NI HRS SYNTHES (USA) NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR PLATE