BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 26MM

    MDR report key: 2902115 · Received January 8, 2013

    Report

    Report Number
    1719045-2013-00069
    Event Type
    Injury
    Date Received
    January 8, 2013
    Report Date
    December 13, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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 BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH A PLATE AND FOUR SCREWS AT THEIR TMT (TARSO-METATARSAL) JOINT (FOOT) ON (B)(6) 2011. (B)(6) POST TMT (TARSO-METATARSAL JOINT) FUSION THE PATIENT RETURNED TO THE SURGEON ON AN UNKNOWN DATE COMPLAINING OF PAIN. SURGEON RETURNED PATIENT TO OPERATING ROOM ON (B)(6) 2012 TO REMOVE ONE PLATE AND FOUR SCREWS. PATIENT WAS REPORTEDLY HEALED, WITH NO FURTHER TREATMENT REQUIRED. THIS IS 5 OF 5 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9021 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 26MM SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention PLATE, SCREWS