BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM CANNULATED LOCKING SCREW70MM

    MDR report key: 2924479 · Received January 22, 2013

    Report

    Report Number
    1719045-2013-00168
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    December 28, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K000066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REPORTED DATE OF IMPLANT WAS (B)(6) 2011. 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 4.5MM LCP PROXIMAL TIBIA PLATE AND SCREWS FOR A LEFT PROXIMAL TIBIA FRACTURE IN (B)(6) 2011. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. PATIENT COMPLAINED OF PAINFUL HARDWARE. PATIENT'S FRACTURE WAS HEALED. THE HARDWARE WAS REMOVED WITHOUT COMPLICATIONS. THIS IS 3 OF 6 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30380 5.0MM CANNULATED LOCKING SCREW70MM CANNULATED LOCKING SCREW HRS SYNTHES MONUMENT

    Patients

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