BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICSCR PANGEAPOLYAX Ø6 CANN PREASSMBL

    MDR report key: 3191911 · Received June 27, 2013

    Report

    Report Number
    2530088-2013-00979
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Report Date
    January 5, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. ADDITIONAL PRODUCT CODE(S) FOR THIS REPORT INCLUDE, MNH, MNI, KWQ, KWP. THE VISUAL INSPECTION HAS SHOWN THAT THERE IS A MISALIGNMENT OF THE CONICAL ELEMENTS. THIS ISSUE WAS PREVIOUSLY EVALUATED, THE PANGEA SCREWS MAY SUFFER FROM THE ABOVE DESCRIBED DAMAGE WHEN HANDLED IN A CERTAIN MANNER. THIS ISSUE HAS BEEN ADDRESSED AND A PREVIOUS INTERNAL ACTION HAS BEEN TAKEN. THE SPIRIT SURGICAL TECHNIQUE GUIDE HAD BEEN ADAPTED AND RELEASED. IN ADDITION, THE PANGEA SCREWS ARE USED WITH SPIRIT, IT IS VITAL TO AVOID PUSHING FORWARD THE HOLDING SLEEVE WHILE INSERTING/ADVANCING THE SCREW INTO THE VERTEBRAE. THE SAME APPLIES WHEN ORIENTING THE HOLDING SLEEVE. NO PRODUCT FAULT COULD BE DETECTED. A REVIEW OF THE MANUFACTURING DOCUMENTS REVEALED THAT THESE PARTS WERE MANUFACTURED ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    ONCE INSERTED THE ROD, THE LOCKING CAP DRIVER FOR PANGEA, WAS USED IN ORDER TO INSERT THE CAP. AFTER THE INSERTION AND THE QUARTER TURN OF THE LOCKING CAP, IT WAS CLEAR THAT THE PANGEA POLYAXIAL HEAD WAS PROPERLY INSERTED ON THE ROD, BUT IT WAS STILL POSSIBLE TO MOVE IT. SURGEON DECIDED TO REMOVE THE CAP, THE ROD AND THEN THE SCREW AND HE REALIZED THAT SOME PARTS OF THE INNER PARTS OF THE SCREW WERE DISSEMBLED. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294807 PEDICSCR PANGEAPOLYAX Ø6 CANN PREASSMBL NKB SYNTHES BRANDYWINE 6545528

    Patients

    Seq Age Sex Outcome Treatment
    1