BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.9MM TI LOCKING BOLT 40MM

    MDR report key: 6901273 · Received September 28, 2017

    Report

    Report Number
    1719045-2017-10995
    Event Type
    Injury
    Date Received
    September 28, 2017
    Report Date
    September 11, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K970733
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT¿S HEIGHT REPORTED AS (B)(6). DATE OF EVENT: UNKNOWN. ADDITIONAL DEVICE PRODUCT CODE: HTY, JDW, JDN, HSB. (B)(4). COMPLAINANT DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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 THAT A TROCHANTERIC FEMORAL NAIL (TFN) REMOVAL AND REVISION WAS PERFORMED ON (B)(6) 2017. THE DATE OF THE ORIGINAL PROCEDURE IS UNKNOWN. SUBSEQUENTLY ON AN UNKNOWN DATE, THE PATIENT SUSTAINED A FALL AND FRACTURED BELOW THE ORIGINAL TFN SITE. REMOVED HARDWARE INCLUDED: THE NAIL, A HELICAL BLADE AND A LOCKING ¿BOLT¿, ALL REMOVED FULLY INTACT. THE PATIENT WAS REVISED TO LONG TROCHANTERIC NAIL. THE ORIGINAL FRACTURE SITE WAS FULLY HEALED AND THE NOTHING UNTOWARD OCCURRED DURING THE REMOVAL/REVISION PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS REPORT IS FOR ONE (1) 4.9MM TI LOCKING BOLT 40MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682396 4.9MM TI LOCKING BOLT 40MM NAIL,FIXATION,BONE JDS SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention