BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM CORTEX SCREW SELF-TAPPING 40MM

    MDR report key: 2931049 · Received January 28, 2013

    Report

    Report Number
    8030965-2013-00237
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K030310
    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 BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    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 O.R. 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 15 OF 17 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36896 2.4MM CORTEX SCREW SELF-TAPPING 40MM CORTEX SELF TAPPING SCREW HRS SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention