BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REDUCTION SPOON 9MM

    MDR report key: 1190559 · Received October 2, 2008

    Report

    Report Number
    9610622-2008-00185
    Event Type
    Injury
    Date Received
    October 2, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 9, 2008
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED, THAT DURING A SURGICAL PROCEDURE, THE GUIDE WIRE WAS INSERTED WITH THE REPOSITION SPOON INTO THE DISTAL FRAGMENT. IN THIS CONNECTION, THE SPOON BROKE AND REMAINED IN THE INTRAMEDULLARY CANAL. A CUT WAS MADE ABOVE THE FRACTURE TO REMOVE THE SPOON PART USING A SPECIAL BENDED WIRE. THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REDUCTION SPOON 9MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K988785

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention