BEUDAMED
    FDA Adverse Event Injury Summary report: N

    7.0MM TI CLICKX PEDICLE SCR PREASSEMBLED 45MM THRD LENGTH

    MDR report key: 2942948 · Received February 5, 2013

    Report

    Report Number
    8030965-2013-00284
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 19, 2012
    Report Date
    January 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IT WAS REPORTED THE PATIENT WAS IMPLANTED TWO YEARS AGO (APPROXIMATELY 2010); DATE UNKNOWN. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH CLICK X CONSTRUCT ON AN UNKNOWN DATE APPROXIMATELY TWO YEARS AGO FOR A FREE HEALTH CAMPAIGN. IN (B)(6) 2012, THE SCREWS WERE NOTED TO BE BROKEN. PATIENT WAS RETURNED TO THE O.R. ON (B)(6) 2013 FOR REMOVAL OF THE BROKEN SCREWS. PATIENT WAS REVISED WITH NEW IMPLANT DURING THE REMOVAL SURGERY. THIS IS 2 OF 2 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48170 7.0MM TI CLICKX PEDICLE SCR PREASSEMBLED 45MM THRD LENGTH SCREW NKB SYNTHES GMBH 3330295

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention