BEUDAMED
    FDA Adverse Event Injury Summary report: N

    135 DEG DHS® PLATE-STD BARREL 2 HOLES/46MM-STERILE

    MDR report key: 3927567 · Received July 10, 2014

    Report

    Report Number
    3003506883-2014-10070
    Event Type
    Injury
    Date Received
    July 10, 2014
    Report Date
    June 12, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    PK791619
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES; JDO. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 A REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT EXPERIENCING PAIN. THE PATIENT¿S FRACTURE DID NOT PROPERLY HEALING. THE FEMORAL HEAD COLLAPSED INTO THE VARUS AND THE DYNAMIC HIP SCREW (DHS) CUT OUT OF THE BONE. THE PATIENT WAS ORIGINALLY TREATED FOR A CERVICAL HIP FRACTURE (TROCHANTERIC/FEMORAL NECK) ON (B)(6) 2014. ON AN UNKNOWN DATE, THE PATIENT PRESENTED WITH PAIN. THE SURGEON CONFIRMED VIA X-RAY THAT THE FEMORAL HEAD COLLAPSED INTO THE VARUS AND THE DYNAMIC HIP SCREW (DHS) CAME OUT OF THE PATIENT¿S BONE. THE SURGEON EXPLANTED ALL HARDWARE, WHICH INCLUDED 1-DHS PLATE, 1-DHS LAG SCREW, 2-4.5 MM CORTEX SCREWS AND 1-7.3 MM CANNULATED SCREW. THE ITEM NUMBERS FOR THE CORTEX AND CANNULATED SCREWS ARE UNKNOWN. THE PATIENT WAS IMPLANTED WITH A BI-POLAR HIP REPLACEMENT SUCCESSFULLY. THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404346 135 DEG DHS® PLATE-STD BARREL 2 HOLES/46MM-STERILE APPLIANCE,FIXATION,NAIL KTT SYNTHES ELMIRA 6730703

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention