BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 30MM

    MDR report key: 2894525 · Received January 3, 2013

    Report

    Report Number
    1719045-2012-01510
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 4, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 TIBIA PLATE AND SCREW CONSTRUCT ON (B)(6) 2011. PATIENT'S 15 MONTH STATUS POST REPORTS A NON-UNION OF PATIENT'S LEFT PROXIMAL TIBIA. ON (B)(6) 2012 PATIENT RETURNED TO THE OR AND THE HARDWARE WAS EXPLANTED. THE SURGEON REALIGNED THE FRACTURE, REMOVED THE FIBROUS TISSUE, ADDED A BONE GRAFT, AND RE IMPLANTED A LONGER LATERAL PLATE AS WELL AS A MEDIAL PLATE. NO INFORMATION ABOUT PATIENT'S RECOVERY WAS PROVIDED. THIS IS 3 OF 9 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2665 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 30MM SCREW HRS SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention PLATE, SCREWS