BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELEVATE SPINAL SYSTEM

    MDR report key: 19904321 · Received August 5, 2024

    Report

    Report Number
    1030489-2024-00927
    Event Type
    Malfunction
    Date Received
    August 5, 2024
    Date of Event
    July 9, 2024
    Report Date
    September 20, 2024
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    MAX
    UDI-DI
    00643169430778
    PMA / PMN Number
    K172199
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS: PRODUCT ID# 8880823; LOT# 1011271W 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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, DISTRIBUTOR) REGARDING A PATIENT HAVING L4-5 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) FOR DIAGNOSED L4-5 HIVD AND GRADE I SPONDYLOSIS. IT WAS REPORTED THAT THE CAGES WERE BROKEN. AFTER DISCECTOMY, THE SURGEON USED TRAIL TO DETERMINE THE SIZE OF IMPLANTS. THE SURGEON INSERTED IMPLANT INTO THE SPACE. WHEN THE HAMMER WAS USED TO HIT THE INSERTER, THE CAGE WAS BROKEN. THEN THE SURGEON REMOVED THE CAGE AND REPLACED WITH THE NEW ONE. HE REPEATED THE SAME PROCEDURE AND CAGE WAS BROKEN. HE REPLACED THE THIRD CAGE AND FINISHED THE SURGERY. THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2294811 ELEVATE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX WARSAW ORTHOPEDICS 8880823 1011271W 00643169430778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown