BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/110MM

    MDR report key: 4591723 · Received March 11, 2015

    Report

    Report Number
    3003506883-2015-10051
    Event Type
    Injury
    Date Received
    March 11, 2015
    Report Date
    February 27, 2015
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    PK964259
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES; JDO. PART/LOT COMBINATION CANNOT BE VERIFIED, THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2015 A DYNAMIC HIP SCREW (DHS) PLATE, LAG SCREW AND FOUR CORTEX SCREWS WERE ALL REMOVED FROM THE A PATIENT DUE TO NONUNION. THERE WAS NO DAMAGE TO DHS PLATE OR FOUR CORTEX SCREWS. THE LAG SCREW WAS BROKEN. THE PLATE, BROKEN LAG SCREW AND CORTEX SCREWS WERE SAFELY REMOVED AND REVISED WITH ANOTHER SYNTHES DHS IMPLANT. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166990 DHS®/DCS® ONE-STEP LAG SCREW 12.7MM THREAD/110MM APPLIANCE,FIXATION,NAIL KTT SYNTHES ELMIRA 627347

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention