BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM

    MDR report key: 2900320 · Received January 7, 2013

    Report

    Report Number
    1719045-2013-00047
    Event Type
    Injury
    Date Received
    January 7, 2013
    Report Date
    December 12, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 3.5MM LCP OLECRANON PLATE AND SCREW CONSTRUCT ON (B)(6) 2011. PATIENT RETURNED TO THE O.R ON (B)(6) 2012. PATIENT GAVE CONSENT FOR REMOVAL OF HARDWARE FROM THE LEFT ELBOW DUE TO HARDWARE PROMINENCE. ALL HARDWARE WAS REMOVED WITHOUT COMPLICATIONS. PATIENT WAS NOT REVISED WITH ANY ADDITIONAL HARDWARE BECAUSE IT IS REPORTED THAT THE PATIENT WAS HEALED. THIS IS 2 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6170 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM SCREW KTT SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention PLATE, SCREWS