BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANKLE ARTHRODESIS NAIL, LEFT 10X150MM

    MDR report key: 1753907 · Received July 8, 2010

    Report

    Report Number
    9610622-2010-00276
    Event Type
    Injury
    Date Received
    July 8, 2010
    Date of Event
    April 19, 2010
    Report Date
    June 18, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K051590
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. NO EVALUATION WILL BE PERFORMED. IF THE DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. ADDITIONAL ASSOCIATED DEVICES: 18180001S COMPRESSION SCREW CANNULATED K932496, 18915040S LOCKING SCREW, PARTIALLY THREADED 5X40 MM K192924, 18965025S LOCKING SCREW, FULLY THREADED 5X25 MM K176568, 18260003S END CAP, (B) (4), 18965025S LOCKING SCREW, FULLY THREADED 5X25 MM K269361.

    Description of Event or Problem · 1

    IT WAS REPORTED, "EXPLANTED BECAUSE PATIENT WAS INFECTED (INCISION WOUND). DID NOT REPLACE WITH ANYTHING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANKLE ARTHRODESIS NAIL, LEFT 10X150MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K455803

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention