BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYRENEES CERVICAL PLATE SYSTEM

    MDR report key: 6194642 · Received December 21, 2016

    Report

    Report Number
    3004774118-2016-00110
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 21, 2016
    Report Date
    November 21, 2016
    Manufacturer
    K2M, INC.
    Product Code
    KWQ
    UDI-DI
    10888857261471
    PMA / PMN Number
    K153526
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION WAS IMMEDIATELY INITIATED ON RECEIPT OF THE COMPLAINT. THE PRODUCT WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION, AND A THOROUGH INVESTIGATION COULD NOT BE COMPLETED AS THE LOT NUMBER HAS NOT BEEN IDENTIFIED/CONFIRMED IN THIS CASE. SINCE THE SCREW REMAINS IN THE PATIENT, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED. BASED ON THE POST-OP X-RAY, ENOUGH OF THE SCREW WAS VISIBLE ABOVE THE PLATE TO REASONABLY SUGGEST THAT IT WAS BACKING OUT. THE SUBJECT SCREW WAS ALSO ANGLED VERY CLOSE TO THE TITANIUM INTERBODY, AND EVEN APPEARED TO HAVE BEEN TOUCHING THE INTERBODY, WHICH MAY HAVE CONTRIBUTED TO THIS INCIDENT, AS THE TORQUE HANDLE COULD HAVE POTENTIALLY TORQUED-OFF BEFORE THE SCREW WAS ACTUALLY LOCKED. AT THIS ANGLE, THE SUBJECT SCREW WAS ALSO AT THE LIMITS OF THE TIFIX LOCKING TECHNOLOGY, WHICH MAY HAVE ALSO CONTRIBUTED TO THIS INCIDENT, AS A BETTER LOCK IS ACHIEVED THE MORE COAXIAL THE SCREW IS WITH THE PLATE HOLE. WHILE NONE OF THE IMPLANTS WERE RETURNED, A GENERAL REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS REVEALED NO ADDITIONAL INFORMATION. REMAINS IN PATIENT.

    Description of Event or Problem · 1

    ON (B)(6) 2016 IT WAS REPORTED TO K2M, INC. THAT APPROXIMATELY SIX WEEKS AFTER THE INDEX SURGERY, A SCREW REPORTEDLY STARTED BACKING OUT. THE INDEX SURGERY TOOK PLACE (B)(6) 2016. THERE ARE NO PLANS TO REVISE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845620 PYRENEES CERVICAL PLATE SYSTEM SPINAL FIXATION SYSTEM KWQ K2M, INC. UNKNOWN 10888857261471

    Patients

    Seq Age Sex Outcome Treatment
    1 6101-2121409CL7 LOT UNKNOWN| 6808-43S9H LOT UNKNOWN