BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE¿ SPINAL SYSTEM

    MDR report key: 11357395 · Received February 22, 2021

    Report

    Report Number
    1030489-2021-00236
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    February 2, 2021
    Report Date
    November 19, 2021
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MAX
    PMA / PMN Number
    K172199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART#7770723 ; LOT#0800620W ANALYSIS SUMMARY: FUNCTIONAL INSPECTION CONFIRMED THE EXPANDING SCREW ON THE BACKSIDE OF THE SPACER HAS BEEN BACKED OUT SO FAR THAT IT WILL NOT REALIGN TO REENGAGE THE THREADS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING REVISION SURGERY OF PLIF AT L4 / 5. IT WAS REPORTED THAT, AFTER PLACING THE REPORTED PRODUCT BETWEEN THE VERTEBRAL BODIES, THE TORQUE HANDLE WITH THE INSERTER DRIVE SHAFT FOR ANTERIOR EXPANDING WAS TURNED UNDER SIDE FLUOROSCOPIC GUIDANCE, BUT THE CAGE DID NOT EXPAND, AND THE TORQUE HANDLE WAS IDLED. THE PRODUCT WAS REMOVED ONCE, AND THE EXPANDING OPERATION WAS PERFORMED USING THE SAME TORQUE HANDLE OUTSIDE THE OPERATIVE FIELD, BUT THE HANDLE IDLED AGAIN. THE ANTERIOR EXPANSION OF CAGE THE COULD NOT BE PERFORMED, SO THE PRODUCT WAS IDENTIFIED AS DEFECTIVE. A NEW PRODUCT OF THE SAME SIZE WAS OPENED, AND THE EXPANDING OPERATION WAS PERFORMED WITH THE SAME INSTRUMENT. THE NEW CAGE WAS ABLE TO BE EXPANDED WITHOUT ANY PROBLEMS USING THE SAME INSTRUMENT. IT WAS UNKNOWN THAT, THE CAGE WAS BROKEN OR NOT. THERE WAS NO MALFUNCTION OF THE PRODUCTS USED IN INITIAL SURGERY CAUSED THIS REVISION. THERE WAS A DELAY OF LESS THAN 60 MINUTES OCCURRED AS A RESULT OF THIS EVENT. THERE WAS NO HEALTH DAMAGE IN PATIENT WAS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257595 ELEVATE¿ SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX WARSAW ORTHOPEDICS 7770723 0800620W

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown