BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS 135° 8HO L142 SST

    MDR report key: 2960274 · Received February 14, 2013

    Report

    Report Number
    8030965-2013-00457
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    October 10, 2012
    Report Date
    January 17, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS RETURNED AND THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT WAS INVOLVED IN A MVA ON (B)(6) 2012 AND SUSTAINED A FRACTURE AT THE LEFT FEMUR. A DHS PLATE AND SCREWS WERE IMPLANTED (B)(6) 2012. PATIENT FELT PAIN ON (B)(6) 2012 AND X-RAY SHOWED THAT THE DHS PLATE WAS BROKEN. PATIENT WAS RETURNED TO OR ON (B)(6) 2012 PLATE AND SEVEN UNBROKEN SCREWS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64173 DHS 135° 8HO L142 SST DHS 135° 8HOLE KTT SYNTHES GMBH 2691464

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention