BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE¿ SPINAL SYSTEM

    MDR report key: 12777001 · Received November 9, 2021

    Report

    Report Number
    1030489-2021-01354
    Event Type
    Malfunction
    Date Received
    November 9, 2021
    Date of Event
    October 18, 2021
    Report Date
    May 18, 2022
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MAX
    UDI-DI
    00643169430433
    PMA / PMN Number
    K172199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS OF PART#7770723 ; LOT#0834418W ANALYSIS SUMMARY: VISUAL AND MICROSCOPIC INSPECTION CONFIRMED THE PEEK PORTION OF THE SPACER HAS BROKEN AWAY FROM THE SPACER. THERE ARE WITNESS MARKS ON THE BACKSIDE OF THE SPACER INDICATING THAT THE SPACER WAS IMPACTED. BOTH OF THE EARS ON THE PEEK PORTION OF THE SPACER HAVE BROKEN OFF INDICATING THAT THE IMPLANT CAME IN CONTACT WITH BONE AND WAS PUSHED BACK, CAUSING THE EARS TO BREAK OFF AND THAT SECTION OF THE IMPLANT TO SEPARATE. THIS TYPE OF DAMAGE IS CONSISTENT WITH EXCESSIVE FORCE. 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED FROM HEALTHCARE PROVIDER VIA MANUFACTURER REPRESENTATIVE REGARDING AN EVENT HAPPENED DURING INTRA-OP FOR A PATIENT UNDERGOING UNKNOWN SPINAL PROCEDURE. THE PRE-OP DIAGNOSIS WAS MENTIONED AS L3-L4-L5 STENOSIS. IT WAS REPORTED THAT BECAUSE THE PEEK PART FELL OFF, THEY ATTACHED THE CAGE THAT WAS ONCE INSERTED TO THE INSERTER AND REMOVED IT WITH A SLAP HAMMER. THEY PREPARED A NEW CAGE AND PLACED IT. THE PEEK PART FELL OFF BECAUSE THEY HAD AN IMPACT WITHOUT NOTICING THAT THE PEEK PART WAS LOOSE WHILE INSERTING THE CAGE. THERE WAS A DELAY OF LESS THAN 60 MINUTES REPORTED AS A RESULT OF THIS EVENT. THE PEEK PART WAS BROKEN WHEN THE CAGE WAS INSERTED. THE CAGE WAS REMOVED AND A NEW ONE OF THE SAME SIZE WAS NEWLY PLACED (USING THE SAME INSERTER). THERE WERE NO SYMPTOMS TO PATIENT OR PHYSICIAN WERE REPORTED. THERE WAS NO ADDITIONAL TREATMENT OR SURGERY PERFORMED AS A RESULT OF THIS EVENT. NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678657 ELEVATE¿ SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX WARSAW ORTHOPEDICS 7770723 0834418W 00643169430433

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male