BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 2883723 · Received December 21, 2012

    Report

    Report Number
    8030965-2012-01643
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    November 22, 2012
    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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION. ADDITIONAL PRODUCT CODES: MNI, MNH, KWP, KWQ. INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES VISUAL INSPECTIONS NOTED THAT THE BAR HAS TWO STRESS FRACTURES BETWEEN THE 4MM AND 6MM DIAMETER. THE POLYMER PART OF THE BARS HOWEVER, APPEARS TO BE INTACT. THE EXACT REASON FOR THIS DAMAGE CANNOT BE IDENTIFIED AFTERWARDS. WE ASSUME THAT AN EXCESSIVE BIAS CAUSED THE BREAK. NO PRODUCT FAULT COULD BE DETECTED. SIX CLICK''X PEDICLE SCREWS WITH NO VISIBLE DAMAGE OR FRACTURE WAS NOTED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH NFLEX ROD CONSTRUCT ON AN UNKNOWN DATE. ON AN UNKNOWN DATE, THE NFLEX CONSTRUCT BROKE. PATIENT RETURNED TO THE OR ON AN UNKNOWN DATE, AND A REVISION SURGERY WAS COMPLETED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS IS 3 OF 6 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS 3 OF 6 REPORTS FOR THE SAME EVENT, COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN CLICKX-3D-HEAD F/PEDICSCR POST-OPEN TAN NKB SYNTHES GMBH 3626177

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCREWS, RODS