BEUDAMED
    FDA Adverse Event Other Summary report: N

    CHEASAPEAKE

    MDR report key: 2379446 · Received November 1, 2011

    Report

    Report Number
    3004774118-2011-00017
    Event Type
    Other
    Date Received
    November 1, 2011
    Date of Event
    October 5, 2011
    Report Date
    November 1, 2011
    Manufacturer
    K2M, INC.
    Product Code
    MAX
    PMA / PMN Number
    K092211
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DAMAGE TO THE IMPLANT UPON REMOVAL APPEARS TO BE CONSISTENT WITH THE REMOVAL TOOL NOT BEING PROPERLY USED. THE TOOL IS DESIGNED TO GO INTO THE HOLES AND GRAB ONTO THE TIFIX SCREW HOLES. IF NOT FULLY INSERTED IN THE SCREW HOLE, IT COULD GRAB ONTO THE PEEK MATERIAL INSTEAD, THERAPY CAUSING DAMAGE TO THE IMPLANT. THE ACTUAL IMPLANT HAS NOT YET BEEN RETURNED TO THE MFR FOR EVAL. THIS IS THE FIRST REPORTED INCIDENT OF THIS KIND. THE MFR WILL CONTINUE TO MONITOR EXPERIENCES WITH THIS DEVICE AND ASSOCIATED INSTRUMENTS IN ORDER TO DETERMINE IF ANY SORT OF ACTION IS NEEDED IN THE FUTURE.

    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 WAS COMPLETED AS THE LOT NUMBER HAS BEEN IDENTIFIED/CONFIRMED IN THIS CASE. SINCE THE BROKEN CAGE HAS BEEN DISCARDED, NO PHYSICAL, CHEMICAL EVALUATION COULD BE PERFORMED, AND THE EXACT CAUSE OF THE REPORTED ISSUE COULD NOT BE ASCERTAINED. A REVIEW OF APPLICABLE MATERIAL, INSPECTION, MANUFACTURING AND DISTRIBUTION RECORDS OF POSSIBLE DEVICE MANUFACTURING DATES ACCORDING TO THE DESCRIPTION OF THE PRODUCTS USED WITH THE CONCOMITANT DEVICE(S) WAS CONDUCTED. ALL RECORDS REVEALED THAT ALL PRODUCTS LOTS WERE MANUFACTURED WITHIN SPECIFICATIONS AND DISTRIBUTED IN ACCORDANCE WITH ALL OPERATING PROCEDURES. A REVIEW OF THE MANUFACTURING AND INSPECTION RECORDS DID NOT REVEAL ANY CONTRIBUTING INFORMATION/TRENDS. A REVIEW OF THE COMPLAINT TRENDS RELATED TO THIS CAGE AND BREAKING DID NOT REVEAL ANY CONTRIBUTING INFORMATION.

    Description of Event or Problem · 1

    SURGEON HAD SOME CHALLENGES IMPLANTING THE CHESAPEAKE CAGE. THE CAGE ROTATED UPON IMPACTION AND INSERTION OF THE SCREWS AND HAD TO BE REMOVED TWICE FOR REPOSITIONING. THE FRONT EDGE OF THE CAGE BROKE UPON THE SECOND REMOVAL. A SECOND CAGE WAS IMPLANTED HOWEVER, THE SURGEON HAD SOME DIFFICULTY ENGAGING THE DRILL GUIDE AND GETTING IT TO STAY IN POSITION. FINAL X-RAY SHOWS GOOD CAGE AND SCREW POSITION. THIS REPORT IS BEING FILED AS A PRECAUTIONARY MEASURE DUE TO THE LENGTH OF TIME THE SURGERY WAS EXTENDED AS A RESULT OF THE CHALLENGES THE SURGEON HAD WITH THE IMPLANT AND INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHEASAPEAKE INTERBODY/CAGE MAX K2M, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other