BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOSKELETON¿ TAS INTERBODY SYSTEM

    MDR report key: 22456294 · Received July 9, 2025

    Report

    Report Number
    3011577940-2025-00001
    Event Type
    Malfunction
    Date Received
    July 9, 2025
    Report Date
    July 9, 2025
    Manufacturer
    TITAN SPINE, A DIVISION OF MEDTRONIC
    Product Code
    OVD
    PMA / PMN Number
    K111626
    Removal / Correction Number
    Z-0085-2022 AND Z-0086-2
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS FOR PART # (B)(4); LOT # A200510 VISUAL AND OPTICAL INSPECTION REVEALED THE IMPLANT RETURNED MATCHED THE PRODUCT PACKAGE. THE IMPLANT IS IN THE RIGHT PRODUCT PACKAGE. NO FAULT FOUND. THE SECOND IMPLANT RETURNED DOES NOT MATCH WHAT IS ON THE LABEL. THESE ARE PACKAGED IN ZIP LOCK BAGS WHICH CAN BE OPENED WITHOUT ANY EVIDENCE OF TAMPERING. UNABLE TO DETERMINE ROOT CAUSE OF WRONG IMPLANT INSIDE THE PACKAGE. H11: ¿THIS REPORT IS BEING SUBMITTED AS PART OF REMEDIATION ACTIVITIES ASSOCIATED WITH CAPA # 643143, WHICH IS ADDRESSING MDR REPORTING GUIDANCE FROM FDAS 1995 PREAMBLE, WHICH ENSURES COMPLAINTS RELATED TO CORRECTIONS AND RECALLS WHICH WERE PREVIOUSLY REPORTED TO FDA UNDER 21 CFR 806 ARE NOW REPORTED AS MDRS; THIS IS NOT A NEW MALFUNCTION/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 USER FACILITY VIA A MANUFACTURER REPRESENTATIVE REGARDING A DEVICE FOR SPINAL THERAPY. IT WAS REPORTED THAT A CERVICAL CAGE (TCS) IMPLANT WAS IN THE LUMBAR ALIF CAGE (TAS) BAG THAT WAS SENT OUT TO THE FIELD. THERE WERE NO PATIENT INVOLVED. THE DEVICE WILL BE REPLACED AND WILL BE RETURNED. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147454 ENDOSKELETON¿ TAS INTERBODY SYSTEM INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED F OVD TITAN SPINE, A DIVISION OF MEDTRONIC 2312-0212 A200323

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown