BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 28MM

    MDR report key: 2942968 · Received February 5, 2013

    Report

    Report Number
    1719045-2013-00250
    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. ADDITIONAL NARRATIVE: 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.

    Additional Manufacturer Narrative · 1

    CORRECTED TYPE OF REPORTABLE EVENT FROM DEATH TO SERIOUS INJURY.

    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 OPERATING ROOM 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 13 OF 14 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49095 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 28MM LOCKING SCREW KTT SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention