BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE, FIXATION, NAIL

    MDR report key: 5483477 · Received March 7, 2016

    Report

    Report Number
    2520274-2016-11491
    Event Type
    Injury
    Date Received
    March 7, 2016
    Report Date
    February 19, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: EVENT DATE: UNKNOWN. THE 510(K): REPORT IS FOR ONE (1) UNKNOWN LAG SCREW. ADDITIONAL PRODUCT CODE ¿ JDO. UNKNOWN WHEN DEVICE WAS IMPLANTED. PATIENT UNDERGOING REVISION SURGERY. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. MFR DATE: UNKNOWN. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 ON (B)(6) 2016, A HARDWARE REMOVAL SURGERY WAS PERFORMED DUE TO PAIN. THE PATIENT HAD A DYNAMIC HIP SCREW PLATE IMPLANTED ON AN UNKNOWN DATE FOR AN INTERTROCHANTERIC FRACTURE AND COMPLAINED OF HIP PAIN. THE SURGEON REMOVED THE PLATE, LAG SCREW, AND FOUR (4) CORTICAL SCREWS SINCE THE PATIENT WAS FULLY HEALED FROM THE INITIAL INJURY. X-RAYS WERE TAKEN INTRA-OPERATIVELY. PATIENT STATUS WAS REPORTED AS ¿OK.¿ PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS MEDWATCH IS TO REPORT THE PATIENT UNDERGOING THE REMOVAL OF THE PLATE AS A RESULT OF HIP PAIN. SEE RELATED COMPLAINT, (B)(4) FOR REPORTED INTRA-OPERATIVE ISSUES. THIS REPORT IS FOR ONE (1) UNKNOWN LAG SCREW. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139480 APPLIANCE, FIXATION, NAIL KTT SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention