BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX

    MDR report key: 2930178 · Received January 25, 2013

    Report

    Report Number
    1719045-2013-00191
    Event Type
    Injury
    Date Received
    January 25, 2013
    Report Date
    January 7, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    JDS
    PMA / PMN Number
    K040762
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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. IMPLANT DATE REPORTED AS UNKNOWN DAY IN (B)(6) 2010.

    Description of Event or Problem · 1

    PATIENT SUFFERED FROM A DISTAL TIBIA FRACTURE AND WAS IMPLANTED WITH TIBIA NAIL AND SCREW CONSTRUCT ON AN UNKNOWN DAY IN (B)(6) 2010. ON AN UNKNOWN DATE, PATIENT REPORTED PAIN. PATIENT RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF HARDWARE. THIS IS 2 OF 6 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35569 TI END CAP WITH T40 STARDRIVE 0MM EXT F/TI TIBIAL NAILS-EX END CAP JDS SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention