BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.9MM TI LOCKING BOLT 46MM

    MDR report key: 7275571 · Received February 15, 2018

    Report

    Report Number
    2939274-2018-50654
    Event Type
    Injury
    Date Received
    February 15, 2018
    Report Date
    January 25, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HTY
    UDI-DI
    10886982231536
    PMA / PMN Number
    K970733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FOR REPORTING. ADDITIONAL PRODUCT CODES: JDW, JDS, JDN, HSB DATE OF IMPLANT REPORTED AS (B)(6) 2010, EXACT DATE IS UNKNOWN. DEVICE WAS NOT EXPLANTED COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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. 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 PATIENT SUSTAINED A BROKEN LEFT FEMUR IN A MOTOR VEHICLE ACCIDENT IN (B)(6) 2010. PATIENT WAS IMPLANTED WITH THE TROCHANTERIC NAIL SYSTEM ON UNKNOWN DATE. PATIENT REPORTS PAIN IN THE LEFT LEG. PATIENT HAS HAD FOLLOW UP VISITS TO THE DOCTOR BUT DOES NOT KNOW IF EXPLANTATION OF THE DEVICES IS PLANNED. X-RAYS TAKEN ON UNKNOWN DATE INDICATE THE BONE IS GROWING OVER THE NAIL. THIS REPORT IS FOR ONE (1) 4.9MM LOCKING BOLT. THIS IS REPORT 5 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117237 4.9MM TI LOCKING BOLT 46MM PIN,FIXATION,SMOOTH HTY WRIGHTS LANE SYNTHES USA PRODUCTS LLC 459.46 10886982231536

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention