BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI SM SYNEX(TM) II ENDPLATE -5 DEG/19MM X 20MM

    MDR report key: 2781854 · Received October 11, 2012

    Report

    Report Number
    8030965-2012-01026
    Event Type
    Injury
    Date Received
    October 11, 2012
    Report Date
    September 13, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    MQP
    PMA / PMN Number
    K061891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 COMPETITOR'S HARDWARE AND SYNEX II ON (B)(6) 2008, IN (B)(6). PATIENT PRESENTED TO THE HOSPITAL ON AN UNKNOWN DATE WITH SEVERE KYPHOSIS. IT WAS DETERMINED THAT THE COMPETITOR'S SYSTEM CONTAINED TWO BROKEN RODS AND THE PATIENT DEVELOPED STENOSIS IN THE CANAL. PATIENT WAS THEN RETURNED TO THE OPERATING ROOM ON (B)(6) 2012, FOR REMOVAL OF COMPETITOR'S HARDWARE AND SYNEX II. PATIENT WAS REVISED TO DEPUY TI EXPEDIUM 6.35. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI SM SYNEX(TM) II ENDPLATE -5 DEG/19MM X 20MM TI SM SYNEX(TM) II ENDPLATE MQP SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention ENDPLATE, CENTRAL BODY