BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE SPINAL SYSTEM

    MDR report key: 11705660 · Received April 22, 2021

    Report

    Report Number
    1030489-2021-00518
    Event Type
    Malfunction
    Date Received
    April 22, 2021
    Date of Event
    March 31, 2021
    Report Date
    October 20, 2021
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MAX
    PMA / PMN Number
    K172199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS #267603214:7770723 LOT# 0811923W VISUAL AND OPTICAL EXAMINATION REVIEW CONFIRMS IMPLANT THREADS DAMAGED. WITNESS MARKS AND MATERIAL DEFORMATION NOTED ON THE THRU HOLE OF THE PEEK ANTERIOR RAMP. THESE OBSERVATIONS ARE CONSISTENT WITH OVERLOAD OF THE IMPLANT 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

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE REGARDING A PATIENT SPINAL THERAPY FOR L3 BURST FRACTURE. IT WAS REPORTED THAT AFTER INSERTING THE CAGE OF L3 / 4, THE EXPANDING OPERATION WAS PERFORMED BUT THE PRODUCT DID NOT EXPAND. NO TORQUE LIMIT WAS APPLIED. THERE WAS DELAY IN PROCEDURE WHICH IS LESS THAN 60 MINUTES. THERE WAS PATIENT INVOLVED IN THE EVENT AND NO SYMPTOMS WERE REPORTED. 2021-APR-01_E1 (REP): ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT AFTER INSERTING THE CAGE INTO THE INT ERVERTEBRAL SPACE, THE CAGE DID NOT EXPEND (LENGTHEN) EVEN WITH PROPER OPERATION. 2021-APR-02_E2 (REP): ADDITIONAL INFORMATION WAS RECEIVED VIA MANUFACTURER REPRESENTATIVE THAT WHEN INSERTED THE ELEVATE CAGE INTO L3 / L4 AND MADE ATTEMPT TO LENGTHEN THE CAGE, THE CAGE DID NOT LENGTHEN. EVEN THOUGH THE SCREWDRIVER WAS TURNED, IT CONTINUED TO ROTATE, BUT THE CAGE DID NOT LENGTHEN, SO USING OF THE REPORTED CAGE WAS GIVEN UP AND ANOTHER CAGE WAS NEWLY OPENED FOR DEALING WITH IT. AFTER FILLING THE BONE GRAFT BEFORE INSERTING THE CAGE, THE LENGTHENING OF THE CAGE WAS CHECKED OUTSIDE THE SURGICAL FIELD, BUT THERE WAS NO ABNORMALITY AT THAT TIME. L2 / L3 ALSO HAD AN ELEVATE CAGE PLACED, BUT THERE WAS NO PROBLEM THERE. THE ORDER OF PLACEMENT WAS L2 / L3 FIRST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603523 ELEVATE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX WARSAW ORTHOPEDICS 7770723 0811923W

    Patients

    Seq Age Sex Outcome Treatment
    1