BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE

    MDR report key: 5972070 · Received September 22, 2016

    Report

    Report Number
    1719045-2016-10701
    Event Type
    Injury
    Date Received
    September 22, 2016
    Report Date
    September 7, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT¿S HEIGHT: (B)(6), BMI (B)(6), PATIENT CASE NUMBER (B)(6). (B)(4). THE PATIENT HAS THE DEVICES SO THEY WILL NOT BE RETURNED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PART #: 04.034.552S, LOT#: 7063322 (STERILE) - 10MM TI CANN TIBIAL NAIL-EX/ PROX BEND 360MM-STERILE. QUANTITY (B)(4). 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 DEVICES ON (B)(6) 2015 FOR A TIBIAL FRACTURE. ON (B)(6) 2016, ALL OF THE HARDWARE DEVICES WERE EXPLANTED DUE TO PAIN; THE EXPLANTED DEVICES WERE ALL INTACT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE PATIENT WAS STABLE FOLLOWING THE SURGERY. THIS REPORT IS 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622082 11MM TI CANN TIBIAL NAIL-EX W/PROX BEND 360MM-STERILE NAIL,FIXATION,BONE JDS SYNTHES MONUMENT 7063322

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention