BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUKON OCT SPINAL SYSTEM

    MDR report key: 8950626 · Received August 30, 2019

    Report

    Report Number
    3004774118-2019-01069
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    March 13, 2018
    Report Date
    August 30, 2019
    Manufacturer
    K2M INC.
    Product Code
    KWP
    UDI-DI
    10888857349315
    PMA / PMN Number
    K171444
    Removal / Correction Number
    3004774118-8/29/2019-003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    STRYKER COMPLETED ITS ACQUISITION OF K2M, INC. (K2M) ON (B)(6) 2018. AS PART OF INTEGRATION ACTIVITIES, STRYKER INITIATED A RETROSPECTIVE REVIEW OF PRODUCT FIELD ACTIONS K2M INITIATED FOR THE PERIOD 2016 TO 2018. ADDITIONALLY, STRYKER SPINE PERFORMED A RETROSPECTIVE REVIEW OF K2M POST MARKET SURVEILLANCE COMPLAINTS. THE PURPOSE OF THIS REVIEW WAS TO ASSESS REPORTABILITY DECISIONS AND ENSURE CONSISTENCY WITH THE STRYKER CORPORATE PROCEDURES AND POLICIES. AS A RESULT OF THAT REVIEW, THIS MDR IS BEING FILED. IN ADDITION, STRYKER CONCLUDED THIS REQUIRED REPORTING PER 21 CFR PART 806 TO FDA (REPORTED (B)(6) 2019). K2M'S INVESTIGATION CONFIRMED THERE WERE YUKON POLYAXIAL SCREWS IN DISTRIBUTION WITH A MANUFACTURING ERROR THAT COULD PREVENT THE SCREW FROM MATING WITH THE SCREW INSERTER OR SET SCREW AS INTENDED. THIS ERROR COULD CAUSE A DEFORMATION OF THE THREADS AND/OR AN INABILITY OF THE SCREW INSERTER OR SET SCREW TO FULLY SEAT WITHIN THE POLYAXIAL SCREW. K2M WAS AWARE OF ONE INSTANCE OF THIS MANUFACTURING ERROR. K2M NOTIFIED CUSTOMERS WITH A RECALL NOTIFICATION LETTER DATED (B)(6) 2018. THE LETTER INSTRUCTED CUSTOMERS TO LOCATE AND SEGREGATE RECALLED PRODUCT, COMPLETE A TRACKING/VERIFICATION FORM, AND RETURN THE PRODUCT TO K2M. ALL PRODUCT WAS RETURNED/RECONCILED. ALL PRODUCT THAT WAS RETURNED AS A RESULT OF RECALL-023 AND ALL AFFECTED PRODUCT IN K2M'S CONTROL PRIOR TO THE RECALL WERE SCRAPPED BY K2M.

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE REPORTED THAT THE SCREW SITE PREPARATION, THE YUKON POLYAXIAL SCREW Ø3.5X14 MM WAS "DIFFICULT TO LOAD SECURELY THE INSERT DRIVER" THE EVENT WAS NOTED DURING A CASE PREPARATION; THERE WAS NO PATIENT INVOLVEMENT. THE CASE WAS SUCCESSFULLY EXECUTED USING ALTERNATIVE SCREWS THAT WERE READILY AVAILABLE TO THE PHYSICIAN. THERE WAS NO HARM TO THE PATIENT AS THE EVENT WAS IDENTIFIED PREOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742416 YUKON OCT SPINAL SYSTEM APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP K2M INC. FUVD 10888857349315

    Patients

    Seq Age Sex Outcome Treatment
    1