BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SPINE FUSION SYSTEM

    MDR report key: 5766561 · Received July 1, 2016

    Report

    Report Number
    3004485144-2016-00134
    Event Type
    Injury
    Date Received
    July 1, 2016
    Date of Event
    June 24, 2016
    Report Date
    December 22, 2016
    Manufacturer
    BIOMET SPINE - BROOMFIELD
    Product Code
    MAX
    PMA / PMN Number
    PK153695
    Removal / Correction Number
    07/01/2016-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 TWO OF THREE FOR THE SAME EVENT, REFERENCE 3004485144-2016-00133-1 AND 3004485144-2016-00136-1.

    Additional Manufacturer Narrative · 1

    THE ASSOCIATED DHR FOR LOT MD51425 WAS REVIEWED. ALL PARTS RELEASED TO THE INVENTORY DID NOT HAVE ANY NON CONFORMANCES ASSOCIATED WITH THEM THAT COULD HAVE LED TO THIS EVENT. SPECIFICALLY, THE HEIGHT, LENGTH, LASER MARKING, LOCKING INSERT FIT, ENDPLATE FIT, ETC. WERE ALL VERIFIED AT RECEIVING INSPECTION AS HAVING MET SPECIFICATION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. THE RETURNED TRANSFORM TLIF HL 7DEGX30LX7H PART# 8227-0707 LOT# MD51425 WAS VISUALLY EXAMINED. IT WAS EVIDENT THAT THE THREADS HAD BEEN DAMAGED LIKELY FROM CROSS-THREADING WHEN FIRST ATTACHING THE INSERTER TO THE IMPLANT, HOWEVER THIS CANNOT BE CONCLUSIVELY DETERMINED. NO OTHER PART OF THE IMPLANT SHOWED ANY SIGNS OF DAMAGE OR IMPROPER ASSEMBLY. 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. UNIQUE IDENTIFIER (UDI) # (B)(4). REPORT TWO OF THREE OR THE SAME EVENT, REFERENCE 3004485144-2016-00133 AND 3004485144-2016-00136.

    Additional Manufacturer Narrative · 1

    PER THE COMPANY REPRESENTATIVE (DESIGN ENGINEER) WHO WAS IN ATTENDANCE OF THE PROCEDURE, THE FOLLOWING OCCURRED DURING THE PROCEDURE: THE INSERTER WAS FULLY SCREWED INTO THE IMPLANT AND THE IMPLANT WAS INTRODUCED INTO THE INTERDISCAL SPACE. AS IT WAS HAMMERED INTO PLACE, THE CONNECTION TO THE INSERTER BEGAN TO LOOSEN INDICATING THAT THE ENDPLATES OF THE IMPLANT WERE NOT FULLY LOCKED IN THE COLLAPSED POSITION AND CAUSED ONE ENDPLATE TO START TO PREMATURELY EXPAND. THIS MAY HAVE BEEN DUE TO AN INITIAL INCOMPLETE OR CROSS-THREADED CONNECTION BETWEEN THE INSERTER AND THE IMPLANT. THE INSERTER WAS THEN RETIGHTENED. HOWEVER THE IMPLANT DID NOT FULLY COLLAPSE AND THEREFORE COULD NOT BE PULLED BACK OUT. THE SURGEON THEN CHOSE TO FULLY EXPAND THE IMPLANT AND CONNECT THE REMOVER INSTRUMENT ALLOWING FOR ULTIMATE EXTRACTION OF THE SPACER. THE RETURNED IMPLANT WAS FUNCTIONALLY CHECKED WITH AN INSERTER. THE INSERTER WAS ABLE TO PROPERLY ATTACH TO THE IMPLANT, HOWEVER THE USE OF A NEW INSTRUMENT AND PERFORMING THE TASK WITHOUT ANY APPLIED LOAD ON THE SPACER MAY HAVE INFLUENCED THE OUTCOME. THE LABELING WAS REVIEWED AND FOUND TO CONTAIN SUFFICIENT INSTRUCTIONS REGARDING PROPER IMPLANT INSTALLATION.

    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
    420594 BIOMET SPINE FUSION SYSTEM ZYSTON TRANSFORM 7DEGX30LX7H MAX BIOMET SPINE - BROOMFIELD N/A MD51425

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention