BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 32MM

    MDR report key: 2931048 · Received January 28, 2013

    Report

    Report Number
    1719045-2013-00196
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 8, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. PLACEHOLDER.

    Description of Event or Problem · 1

    PATIENT SUFFERED A DISTAL TIBIA FRACTURE AND WAS IMPLANTED WITH ONE-THIRD TUBULAR PLATE WITH COLLAR, LC-DCP 8 HOLE PLATE, MEDIAL DISTAL TIBIA PLATE, LC-DCP 4 HOLE PLATE, AND CORTEX SCREW CONSTRUCT ON (B)(6) 2011. ON AN UNKNOWN DATE, PATIENT REPORTED PAIN AT IMPLANT SITE. PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2013, FOR REMOVAL OF HARDWARE. IT IS REPORTED THAT PATIENT WAS HEALED AND WAS NOT REVISED WITH ANY OTHER HARDWARE. THIS IS 8 OF 17 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37460 3.5MM STARDRIVE CORTEX SCREW SELF-TAPPING 32MM CORTEX SCREW HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention