BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI CLICK'X® LOCKING CAP FOR TI 3-D HEAD

    MDR report key: 3932781 · Received July 14, 2014

    Report

    Report Number
    1000562954-2014-10131
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Report Date
    June 16, 2014
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    NKB
    PMA / PMN Number
    PK082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAMES: MNI, MNH, KWP, KWQ. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PD EVENT EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE SITUATION AS DESCRIBED IN THE COMPLAINT IN PERU COULD NOT BE REPLICATED. THE DAMAGE OF THE HEX DRIVE OF THE LOCKING CAPS, WHICH INDICATES CLOCK WISE AND COUNTER CLOCK WISE LOADING OF THE SET SCREWS, MIGHT BE A SIGN THAT WRONG HANDLING HAS BEEN THE CAUSE OF THE CLOGGING OF THE SET SCREWS. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING PREPARATION, PRIOR TO SURGERY, THE NURSE NOTICED THAT THE CLICK' X CAPS WERE BLOCKED. THE DEVICES WERE NOT USED FOR THE SURGERY. THE EVENT DID NOT PROLONG SURGERY. THIS IS REPORT 10 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409868 TI CLICK'X® LOCKING CAP FOR TI 3-D HEAD ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB SYNTHES MEZZOVICO 8904766

    Patients

    Seq Age Sex Outcome Treatment
    1