BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPINE FUSION SYSTEM

    MDR report key: 5766688 · Received July 1, 2016

    Report

    Report Number
    3004485144-2016-00136
    Event Type
    Injury
    Date Received
    July 1, 2016
    Date of Event
    June 24, 2016
    Report Date
    March 21, 2017
    Manufacturer
    BIOMET SPINE - BROOMFIELD
    Product Code
    MAX
    PMA / PMN Number
    PK153695
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REPORT THREE OF THREE FOR THE SAME EVENT, REFERENCE 3004485144-2016-00133 AND 3004485144-2016-00134.

    Additional Manufacturer Narrative · 1

    INITIAL SUBMISSION WAS ERRONEOUSLY SUBMITTED AS A 5 DAY REPORT. THE FIRM WAS NOT REQUIRED TO INITIATE ACTION TO PREVENT AN UNREASONABLE RISK OF SUBSTANTIAL HARM. SUPPLEMENTAL REPORT THREE OF THREE FOR THE SAME EVENT, REFERENCE 3004485144-2016-00133-1 AND 3004485144-2016-00134-1.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS EVALUATED. IT OPERATED AS EXPECTED WHEN TESTED WITH MATING IMPLANTS; THE COMPLAINT COULD NOT BE CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT IDENTIFY ANY ISSUES WHICH WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    IT IS REPORTED DURING A L5-S1 TLIF PROCEDURE THE SURGEON ATTEMPTED TO PLACE A 7 MM X 30 MM IMPLANT, BUT DURING INSERTION ONE OF THE ENDPLATES STARTED TO EXPAND WHEN IT SHOULD HAVE BEEN LOCKED FORWARD. IT IS BELIEVED THAT THE IMPLANT MAY NOT HAVE BEEN LOADED ON THE INSERTER PROPERLY. THE SURGEON REMOVED THAT IMPLANT AND THEN PLACED AND EXPANDED A 7MM X 25MM IMPLANT USING A NEW INSERTER AND ACTUATED THE LOCKING MECHANISM BUT THE X-RAY INDICATOR IN THE LOCKING MECHANISM DID NOT CONFIRM THAT THE IMPLANT WAS LOCKED. THE IMPLANT WAS REMOVED AND APPEARED LOCKED EXTERNALLY. A SECOND IMPLANT OF THE SAME LOT WAS PLACED, EXPANDED, AND THE LOCKING MECHANISM ACTUATED, BUT ONCE AGAIN THE X-RAY INDICATOR SHOWED THAT THE IMPLANT WAS NOT LOCKED. AT THIS POINT THE SURGEON MADE THE DECISION TO LEAVE THE IMPLANT AS IT WAS THOUGHT THAT THE LOCK WAS LIKELY SECURED AND ADDED BONE GRAFT AS WELL AS FORCE FROM THE SURROUNDING VERTEBRAL BODIES WOULD HELP THE IMPLANT TO MAINTAIN ITS POSITION AND EXPANDED FORM. THIS WAS FOLLOWED BY CLOSURE OF THE SURGICAL SITE AND COMPLETION OF THE PROCEDURE. NO SURGICAL DELAY IN EXCESS OF THIRTY MINUTES WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419959 BIOMET SPINE FUSION SYSTEM ZYSTON TRANSFORM INSERTER MAX BIOMET SPINE - BROOMFIELD N/A MC46064

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention