BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 26MM

    MDR report key: 2942949 · Received February 5, 2013

    Report

    Report Number
    1719045-2013-00246
    Event Type
    Injury
    Date Received
    February 5, 2013
    Report Date
    January 9, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    KTT
    PMA / PMN Number
    K000684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE REPORTED DATE OF IMPLANT WAS 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 ON AN UNKNOWN DATE IN 2011 WITH PLATE, SCREWS, AND CABLE FIXATION FOR A DISTAL HUMERUS FRACTURE. PATIENT PRESENTED TO THE SURGEON ON AN UNKNOWN DATE. EXAMINATION AND X-RAYS REVEALED A NON-UNION OF THE HUMERUS. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013. SURGEON REMOVED THE ENTIRE CONSTRUCT- 1 PLATE, 1 CORTEX SCREW, 2 CANCELLOUS SCREWS, 9 LOCKING SCREWS, AND 1 CABLE. SURGEON ALSO REMOVED AN UNKNOWN NON-SYNTHES RESIN TYPE BONE FILLER AT THE AREA OF THE NON-UNION. PATIENT WAS REVISED TO A NEW PLATE AND SCREW FIXATION, AND ILIAC CREST BONE GRAFT. PATIENT IS REPORTEDLY RECOVERING WELL. THIS IS 9 OF 14 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48342 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 26MM LOCKING SCREW KTT SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention