BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PYRENEES CERVICAL PLATE SYSTEM

    MDR report key: 6326962 · Received February 13, 2017

    Report

    Report Number
    3004774118-2017-00003
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Date of Event
    January 17, 2017
    Report Date
    January 17, 2017
    Manufacturer
    K2M, INC.
    Product Code
    KWQ
    UDI-DI
    10888857031166
    PMA / PMN Number
    K063544
    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 SUBJECT PRODUCT HAS NOT BEEN RETURNED FOR EVALUATION. INVESTIGATION IS STILL IN PROCESS. WHEN INVESTIGATION OF THE SUBJECT PART IS COMPLETE, K2M INC. WILL FILE A SUPPLEMENTAL REPORT INDICATING THE FINDINGS. IN SITU.

    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. THE FRACTURE OCCURRED THROUGH THE PLATE'S SCREW HOLES (SECOND ROW OF SCREW HOLES FROM THE BOTTOM OF THE CONSTRUCT), WHICH IS WHERE PLATES TYPICALLY FRACTURE DUE TO THE REDUCTION IN CROSS-SECTIONAL AREA. THE X-RAY WAS ALSO ANALYZED FOR ANY SIGNS OF FUSION/NON-UNION, BUT NO DETERMINATIONS COULD BE MADE DUE TO THE QUALITY OF THE X-RAY. IN CLOSING, NO ROOT CAUSES COULD BE DETERMINED, AS THE PLATE WAS LEFT IN THE PATIENT AND COULD NOT BE ANALYZED, AND NO CONCLUSIONS COULD BE DRAWN FROM THE PROVIDED X-RAY. THE COMPLEXITY OF THE CASE, HOWEVER, MAY HAVE CONTRIBUTED TO THIS INCIDENT, AS THE PLATE FRACTURED JUST BELOW THE CORPECTOMY CAGE. WHILE NONE OF THE IMPLANTS WERE RETURNED, A GENERAL REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS REVEALED NO ADDITIONAL INFORMATION. IN SITU.

    Description of Event or Problem · 1

    ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A FRACTURED 3 LEVEL PLATE. THE PATIENT REPORTEDLY HAD A FRACTURED 3 LEVEL PLATE APPROXIMATELY 5 MONTHS POST-OP. THERE HAS BEEN NO REVISION SURGERY TO DATE.

    Description of Event or Problem · 1

    ON (B)(6) 2017 IT WAS REPORTED TO K2M, INC. THAT A PATIENT PRESENTED WITH A FRACTURED 3 LEVEL PLATE. THE PATIENT REPORTEDLY HAD A FRACTURED 3 LEVEL PLATE APPROXIMATELY 5 MONTHS POST-OP. THERE HAS BEEN NO REVISION SURGERY TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108598 PYRENEES CERVICAL PLATE SYSTEM ANTERIOR CERVICAL PLATE KWQ K2M, INC. UNKNOWN 10888857031166

    Patients

    Seq Age Sex Outcome Treatment
    1