BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 315MM-STERILE

    MDR report key: 4618104 · Received March 19, 2015

    Report

    Report Number
    3000270450-2015-10065
    Event Type
    Injury
    Date Received
    March 19, 2015
    Report Date
    March 6, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JDS
    PMA / PMN Number
    PK040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. MANUFACTURING DATE: 12.FEB.2013, EXPIRY DATE: 01.JAN.2022. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS DHR IS FOR STERILIZATION PROCEDURE ONLY. NON-STERILE DHR 04.034.243 / 7212576 WAS MANUFACTURED IN US. 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

    ADDITIONAL NARRATIVE: 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 PATIENT PRESENTED FOR REVISION TIBIAL NAIL DUE TO NONUNION. ORIGINAL NAIL WAS EXTRACTED. THE PATIENT'S RIGHT LEG WAS REAMED AND AN APPROPRIATE SIZE NAIL WAS INSERTED. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    188215 8MM TI CANN TIBIAL NAIL-EX W/PROX BEND 315MM-STERILE NAIL, FIXATION, BONE JDS SYNTHES SELZACH 7212576

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention