BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI CLICKX LOCKING CAP FOR TI3-D HEAD

    MDR report key: 3092403 · Received May 3, 2013

    Report

    Report Number
    2520274-2013-02325
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    February 20, 2013
    Report Date
    April 5, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    MNH
    PMA / PMN Number
    K992739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. PLACEHOLDER.

    Description of Event or Problem · 1

    ON (B)(6) 2013, A SURGERY WAS PERFORMED FOR AN L1 FRACTURE USING THE CLICKX SYSTEM L2-T12. AN X-RAY TAKEN POST-OPERATIVELY ON (B)(6) 13 REVEALED AN ISSUE WITH THE CLICKX SYSTEM. IT IS UNCLEAR IF THE CLICKX 3-D HEAD WITH CAP CAME OFF OF THE BONE SCREW, OR IF IT WAS JUST THE CAP. A FUTURE REVISION SURGERY IS PLANNED ON AN UNDETERMINED DATE. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194929 TI CLICKX LOCKING CAP FOR TI3-D HEAD MNH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention