BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS

    MDR report key: 3831675 · Received May 26, 2014

    Report

    Report Number
    2520274-2014-11616
    Event Type
    Injury
    Date Received
    May 26, 2014
    Report Date
    May 7, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    PMA / PMN Number
    PK000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. 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 A TIBIAL NAIL WAS REMOVED DUE TO AN INFECTION. THE PATIENT WAS ORIGINALLY TREATED FOR A DISTAL TIBIA FRACTURE ON (B)(6) 2014. IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT¿S WOUND DEVELOPED PUS AND ON AN UNKNOWN DATE THE SURGEON CONFIRMED BY CULTURE THAT THE PATIENT HAD DEVELOPED AN UNKNOWN TYPE OF INFECTION. THE PATIENT'S HARDWARE WAS EXPLANTED, ANTIBIOTICS WERE ADMINISTERED AND SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SURGICAL DELAY, THE PRODUCT IS NOT BEING RETURNED. THIS IS REPORT 6 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309907 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 40MM FOR IM NAILS SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention