BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI LOCKING SCREW 44MM- FOR IM NAILS

    MDR report key: 3181249 · Received June 21, 2013

    Report

    Report Number
    2520274-2013-03566
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K000089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, THE PATIENT WAS IMPLANTED WITH A TFN NAIL. UPON FOLLOW-UP WITH THE SURGEON, THE PATIENT COMPLAINED THAT THE TFN NAIL CAUSED HIM PAIN. PER THE PATIENT¿S REQUEST, HE WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR HARDWARE REMOVAL. THE DEVICES WERE EASILY REMOVED AND THERE WERE NO REPORTED PROBLEMS DURING SURGERY. THE PATIENT IS EXPECTED TO RECOVER NORMALLY. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282273 5.0MM TI LOCKING SCREW 44MM- FOR IM NAILS HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention