BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM

    MDR report key: 3121550 · Received May 21, 2013

    Report

    Report Number
    2520274-2013-02708
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 23, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    PMA / PMN Number
    K113364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE, THE PATIENT WAS IMPLANTED WITH HARDWARE IN THE LEFT FOOT. THE PATIENT DEVELOPED PAIN ON AN UNKNOWN DATE. REVISION SURGERY TOOK PLACE ON (B)(6) 2013 TO REMOVE THE PAINFUL HARDWARE. A BROKEN PLATE, SCREWS, AND PENTACLE SCREWS WERE REMOVED. THE FRACTURE HAD HEALED. A 2.7MM LOCKING SCREW AND A 2.7MM CORTEX SCREW WERE FOUND TO BOTH HAVE THE HEAD REMOVED. THE SHAFTS OF BOTH SCREWS REMAIN IMPLANTED. THIS IS REPORT 5 OF 10 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224714 2.7MM LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention