BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLICKX PEDICSCR Ø6.2 CANN PREASSMBL L50

    MDR report key: 3121878 · Received May 21, 2013

    Report

    Report Number
    8030965-2013-02291
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    March 4, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. (B)(6). THE DHR WAS REVIEWED AND NO ISSUES THAT WOULD HAVE RESULTED IN THIS COMPLAINT WERE FOUND. THE RECIEVED CONDITION OF THE PART DETECTED THAT THE CLOSING CONE WAS COMPLETELY DESTROYED, WHICH DISABLED AND HINDERED THE POLYAXIAL MOVEMENT. THE PRODUCTION AND MATERIAL DOCUMENTATION SHOW THAT ITS PRODUCTION MEETS ALL SPECS. IN ADDITION, IT WAS DETECTED THAT THE CLOSING CONE WAS COMPLETELY DESTROYED, WHICH DISABLED AND HINDERED THE POLYAXIAL MOVEMENT. THIS PART WAS MANUFACTURED ACCORDING TO THE SPECIFICATIONS. NO PRODUCTION ERROR WAS ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW COULD NOT BE RE-MOBILIZED. THE SCREW WAS FOUND TO BE MONO-AXIAL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224737 CLICKX PEDICSCR Ø6.2 CANN PREASSMBL L50 NKB SYNTHES GMBH 3693722

    Patients

    Seq Age Sex Outcome Treatment
    1