BEUDAMED
    FDA Adverse Event Injury Summary report: N

    130 DEG DHS® PLATE-STANDARD BARREL 6 HOLES/110MM

    MDR report key: 6111862 · Received November 17, 2016

    Report

    Report Number
    3003506883-2016-10185
    Event Type
    Injury
    Date Received
    November 17, 2016
    Report Date
    October 28, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL CODE: JDO. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PART #: 281.16, LOT#: 3961758 (NON-STERILE) - 135 DEG DHS PLATE STANDARD BARREL 6 HOLES/110MM. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 A PATIENT WAS IMPLANTED WITH A 6 HOLE DYNAMIC HIP SCREW (DHS) PLATE, A DYNAMIC HIP SCREW, AND FIVE (5) LARGE FRAG 4.5MM CORTEX SCREWS ON (B)(6) 2016 TO TREAT A NON-UNION OF A LEFT FEMUR FRACTURE. ON (B)(6) 2016, THE PATIENT SUFFERED AN ADDITIONAL FRACTURE DISTAL TO THE DHS PLATE. ON (B)(6) 2016, THE PATIENT WAS RETURNED TO THE OPERATING ROOM TO REMOVE THE IMPLANTED DEVICES. THE DEVICES WERE REMOVED WITHOUT DIFFICULTY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS 1 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761171 130 DEG DHS® PLATE-STANDARD BARREL 6 HOLES/110MM APPLIANCE, FIXATION, NAIL KTT SYNTHES ELMIRA 3961758

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention