BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN

    MDR report key: 2956930 · Received February 12, 2013

    Report

    Report Number
    8030965-2013-00432
    Event Type
    Injury
    Date Received
    February 12, 2013
    Report Date
    January 9, 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

    ADDITIONAL PRODUCT CODES: MNH, MNI, KWP, KWQ. PART(S) RETURNED ON (B)(4) 2013. THE COMPLAINED ARTICLE WAS EVALUATED BY THE SYNTHES (B)(4) PRODUCT DEVELOPMENT CENTRE AND THE REPORT STATES THE FOLLOWING: THE EXACT CAUSE OF THIS DAMAGE COULD NOT BE ELICITED. IT WAS ESTABLISHED THAT THE PARTS HAVE SLIGHT SIGNS OF ABRASION. THE COMPLAINT CONDITION IS LIKELY THE RESULT OF THE HEAD NOT BEING CLICKED RIGHT ON THE BONE SCREW HEAD WHEN THE TORQUE LIMITER WAS USED. THEREFORE, IT WAS CRACKED AND LED TO A DISLOCATION OF THE RODS. BASICALLY IT IS NOT POSSIBLE ACCORDING TO THE TRACES OF THE LOCKING CAPS TO ELICIT, WHICH WAS LEADING TO THE MOVEMENT OF THE RODS. NO FURTHER INDICATION COULD BE MADE BECAUSE OF INSUFFICIENT INFORMATION. THE REVIEW OF THE MANUFACTURING AND MATERIAL DOCUMENTS SHOWS NO DEVIATION ACCORDING TO OUR SPECIFICATIONS. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE 510K/PMA NUMBER WAS REPORTED AS K992739 IN THE INITIAL MEDWATCH ID (B)(4). THE CORRECT 510K/PMA NUMBER IS K082572. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    THIS IS REPORT 9 OF 14 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH CLICK X BETWEEN L3-L5 ON AN UNKNOWN DAY IN (B)(6) 2012. POST OPERATIVELY, IT IS REPORTED THAT THE RODS HAD DISLOCATED. IT IS REPORTED THAT THE REASON OF THE RODS DISLOCATING IS UNKNOWN. PATIENT WAS REVISED ON AN UNKNOWN DAY IN (B)(6) 2012. THIS IS 9 OF 14 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61734 CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN CLICKX PEDICLE SCREW HEAD NKB SYNTHES GMBH 7628753

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention