BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVEREST ® SPINAL SYSTEM

    MDR report key: 8977605 · Received September 9, 2019

    Report

    Report Number
    3004774118-2019-01068
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    September 29, 2016
    Report Date
    August 30, 2019
    Manufacturer
    STRYKER-SPINE
    Product Code
    LXH
    UDI-DI
    10888857041059
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    3004774118-8/28/19-002-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. 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 29 AUGUST 2019). AS PART OF THE REPORTED EVENT INVESTIGATION, K2M IDENTIFIED INSTRUMENTS THAT WERE DEVELOPED WITHOUT ADEQUATE CONSIDERATION GIVEN THE NEED FOR A NEW REGULATORY FILING. ON (B)(6) 2016, K2M NOTIFIED CUSTOMERS WITH A RECALL NOTIFICATION LETTER, INSTRUCTING CUSTOMERS TO LOCATE AND SEGREGATE RECALLED PRODUCT, COMPLETE A TRACKING/VERIFICATION FORM AND RETURN THE PRODUCT TO K2M. ALL PRODUCT WAS RETURNED/RECONCILED. K2M REINTRODUCED THE PRODUCT TO THE MARKET FOLLOWING FDA 510K APPROVAL (K171321). K2M CONCLUDED THE INVESTIGATION OF THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION. FOLLOW-UP WITH THE K2M REPRESENTATIVE PRESENT FOR THE CASE INDICATED THAT THEY DID NOT OBSERVE ANY SUCH INCIDENT. THE K2M REPRESENTATIVE STATED THAT TWO K2M SCREWS WERE REDIRECTED AFTER THEIR INITIAL INSERTION, BUT THIS WAS NOT A DEVICE OR INSTRUMENT FAILURE. RATHER, THIS TYPE OF SCREW REDIRECTION IS COMMON DURING PROCEDURES THAT UTILIZE NAVIGATION; THE NAVIGATION SYSTEM ALLOWS THE SURGEON TO VISUALIZE THE PRECISE LOCATION OF THE INSERTED DEVICE AND TO SUBSEQUENTLY ADJUST OR REDIRECT ITS POSITIONING UNTIL IT IS IN THE OPTIMAL LOCATION. REGARDING THE COMPETITOR LETTER'S ALLEGATION THAT WHEN THE DRIVER WAS TESTED BY THE ONSITE (COMPETITOR) REP, IT WAS FOUND TO SHOW A DISTANCE TO DIVOT VALUE 43MM OFF AND THAT THE SURGEON EXCHANGED THE K2M DRIVER FOR A COMPETITOR DRIVER AND REDID THE HOLES AND INSTALLED THE SPINE SCREWS IN THE PROPER PLACE, K2M CONCLUDED THE FOLLOWING: THE K2M REPRESENTATIVE ALSO CONFIRMED THAT ONLY K2M SCREWS AND DRIVERS WERE UTILIZED DURING THIS CASE. AT NO POINT DID THE SURGEON SWITCH OUT THE K2M DRIVER FOR A NON-K2M DRIVER. IF THIS WERE TO OCCUR, THE NON-K2M DRIVER WOULD HAVE BEEN ENTIRELY UNABLE TO INTERFACE WITH THE K2M SCREWS, AND SO NON-K2M SCREWS WOULD HAVE ALSO BEEN REQUIRED. IF THE K2M DRIVER IN QUESTION EXHIBITED THE ALLEGED 43 MM DISCREPANCY, IT LIKELY WOULD NOT HAVE REGISTERED WITH THE NON-K2M NAVIGATION SYSTEM SUCCESSFULLY AND, ACCORDINGLY, COULD NOT HAVE BEEN USED. A REVIEW OF K2M SALES RECORDS REVEALED THAT A FULL K2M CONSTRUCT WAS UTILIZED DURING THE SUBJECT CASE. THIS ALIGNS WITH THE K2M REPRESENTATIVES' STATEMENTS AND IT CONFLICTS WITH THE ALLEGED USE OF THE NON-K2M SCREWS.

    Description of Event or Problem · 1

    K2M WAS COPIED ON A LETTER FROM A COMPETITOR TO THE FDA THAT ALLEGED THAT, DURING A SPINE FUSION PROCEDURE, A K2M DRIVER WAS BEING USED WITH THE COMPETITORS NAVIGATION SYSTEM, MALFUNCTIONED DURING SURGERY (COMPETTITOR LETTER). ACCORDING TO THE COMPETTITOR LETTER, NO PATIENT HARM OCCURED. THE LETTER DID ALLEGE, THOUGH THAT DURING THE SURGERY THERE WAS INACCURATE SCREW PLACEMENT AND FURTHER ALLEGED THAT SUCH PLACEMENT RESULTED FROM A K2M DRIVER BEING USED WITH THE COMPETTITOR NAVIGATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767807 EVEREST ® SPINAL SYSTEM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT,, PRODUCT CODE: LXH STRYKER-SPINE 10888857041059

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR