BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿

    MDR report key: 20223623 · Received September 16, 2024

    Report

    Report Number
    3006340236-2024-00011
    Event Type
    Malfunction
    Date Received
    September 16, 2024
    Report Date
    September 16, 2024
    Manufacturer
    TITAN SPINE
    Product Code
    MAX
    UDI-DI
    00763000128494
    PMA / PMN Number
    K212524
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE IS UNKNOWN. H6 - 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. 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 HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH ANTERAL IGN CAGE HAVING SPINAL THERAPY FOR LUMBAR SPINAL STENOSIS. IT WAS REPORTED THAT CAGE WAS MISALIGNED, HALF COMING OFF AND SO BONE FUSION COULD NOT BE ACHIEVED. THE INITIAL CASE, WHICH WAS CHANGED FROM DD (CLYDESDALE PTC) TO AG (ANTERALIGN TL), WAS USED IN THE SAME WAY AS WHEN USING DD. THE OPERATION WAS COMPLETED WHEN THE LEFT SIDE WAS SLIGHTLY REMOVED DURING THE INITIAL STAGE USING AG WITH L1-2. AN X-RAY CONFIRMED THAT THE HALF OF THE CAGE WAS REMOVED. DD WAS USED PREVIOUSLY AND IT WAS OVERRUN, SO IT WAS SWITCHED TO AG, BUT THE AG HAS ALSO FALLEN OUT. PATIENT'S SYMPTOMS IMPROVED AND THERE WERE NO PATIENT SYMPTOMS REPORTED. THERE WAS NO PLAN FOR THE REVISION SURGERY AT THIS TIME. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113547 ANTERALIGN¿ SPINAL SYSTEM WITH TITAN NANOLOCK¿ INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX TITAN SPINE 46261055 UNKNOWN 00763000128494

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown