BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI 3-D HEAD FOR TI CLICK X SCREWS

    MDR report key: 3024126 · Received March 27, 2013

    Report

    Report Number
    8030965-2013-01173
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNI
    PMA / PMN Number
    K992739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH CLICK X HARDWARE AT L4-S1 ON (B)(6) 2011. ON AN UNKNOWN POST-OPERATIVE DATE, THE RIGHT POLYAXIAL TULIP HEAD POPPED OFF THE HEAD OF THE SCREW, CAUSING A NON-UNION. PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REVISION SURGERY. AT THIS TIME, SURGEON REMOVED THREE LOCKING CAPS, TWO POLYAXIAL TULIP HEADS, ONE SCREW, AND ONE ROD. AFTER REMOVING ORIGINAL IMPLANTS, SURGEON FURTHER DECOMPRESSED AFTER FINAL TIGHTENING. THIS IS 7 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127291 TI 3-D HEAD FOR TI CLICK X SCREWS MNI SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention