BEUDAMED
    FDA Adverse Event Injury Summary report: N

    90 DEG ADOLESCENT OSTEOTOMY

    MDR report key: 1905796 · Received November 19, 2010

    Report

    Report Number
    1719045-2010-00343
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    May 27, 2010
    Report Date
    November 3, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KTW
    PMA / PMN Number
    K914546
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS NOT PROVIDED DURING THE INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SYNTHES IS UNABLE TO PROVIDE THE DATE OF MANUFACTURE AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. WITHOUT A LOT NUMBER A DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED.

    Description of Event or Problem · 1

    PATIENT STATUS POST ADOLESCENT PLATE IMPLANT RETURNED TO SURGEON. AN X-RAY SHOWED THE PLATE WAS BROKEN. SURGEON WAS PERFORMING THE REVISION PROCEDURE AND AS HE WAS REMOVING THE PLATE THE TIP OF THE PLATE BROKE OFF INSIDE THE HEAD OF THE FEMUR. THE TIP WAS NOT REMOVED. SURGEON REVISED THE PATIENT TO AN ADULT OSTEOTOMY PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 90 DEG ADOLESCENT OSTEOTOMY ADOLESCENT OSTEOTOMY PLATES KTW SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention SCREW