BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERIDIAN

    MDR report key: 21816609 · Received April 10, 2025

    Report

    Report Number
    3012120772-2025-00017
    Event Type
    Malfunction
    Date Received
    April 10, 2025
    Date of Event
    March 17, 2025
    Report Date
    May 8, 2025
    Manufacturer
    SEASPINE ORTHOPEDICS CORPORATION
    Product Code
    MAX
    PMA / PMN Number
    K200879
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO H3: DEVICE EVALUATED BY MANUFACTURER CHANGED TO "YES". INVESTIGATION CONCLUSION: THE RA1-241615 NO-PROFILE INTERBODY, 43MM X 30MM X 16MM, 15 DEG WAS RETURNED AND EVALUATED BY QUALITY AND PRODUCT ENGINEERS ON 18-APR-2025. WHEN VISUAL INSPECTION WAS PERFORMED, SLIGHT DAMAGE AND MISMATCH OF FIT LINES WAS IDENTIFIED. THE DAMAGE WAS TO THE INSTRUMENT ATTACHMENT LIP, WHERE A PIECE OF THE PEEK INTERBODY WAS MISSING. ROOT CAUSE: THE DAMAGED PIECE OF INTERBODY HAS EXCESS MATERIAL PUSHED UP INTO THE FACEPLATE SPACE, NOT PUSHED DOWN AWAY FROM THE FACEPLATE, WHICH PREVENTED A CLEAR FIT. THE FACEPLATE WAS REMOVED AND NO DAMAGE FROM FACEPLATE WAS IDENTIFIED ALONG CONTACTED SURFACES, AS IS SOMETIMES SEEN WHEN A FACEPLATE IS ASSEMBLED WHILE MISALIGNED. THE SOURCE OF THE DAMAGE TO THE INTERBODY COULD NOT BE IDENTIFIED, BUT DAMAGE LIKELY RESULTED IN THE UNEVEN FIT OBSERVED BY THE SURGEON.

    Additional Manufacturer Narrative · 0

    H3: INTERBODY HAS BEEN RETURNED, BUT OUTCOME OF THE INVESTIGATION IS STILL PENDING. REVIEW OF LABELING: POSSIBLE ADVERSE EVENTS BENDING, DISASSEMBLY, OR FRACTURE OF IMPLANT AND COMPONENTS.

    Description of Event or Problem · 0

    DURING A SURGERY ON (B)(6) 2025, THE SURGEON NOTICED THE INSERTER WAS NOT SEATED PROPERLY WITH THE MERIDIAN NO-PROFILE INTERBODY DURING IMPACTION. UPON FURTHER INSPECTION, IT APPEARED THE MERIDIAN NO-PROFILE INTERBODY APPEARED TO HAVE A VERY SMALL BROKEN OFF SECTION. CUSTOMER STATES DAMAGE LIKELY OCCURRED WHILE PLATE WAS BEING INSERTED INTO THE NO-PROFILE INTERBODY DEVICE, HOWEVER, IT WAS NOT DIRECTLY OBSERVED BY THE SCRUB TECH OR OTHER PERSONNEL. SURGEON STATES THEY DID NOT OBSERVE ANY FRAGMENTS IN THE SURGICAL SITE, HOWEVER, THE PIECE THAT WAS BROKEN OFF WAS NEVER RECOVERED. CUSTOMER CONFIRMS THERE WAS NO PATIENT INJURY OR CLINICALLY SIGNIFICANT DELAY IN SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A BACK-UP DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460356 MERIDIAN NO-PROFILE INTERBODY, 43MM X 30MM X 16MM, 15 DEG MAX SEASPINE ORTHOPEDICS CORPORATION RA1-241615 EM2201044A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other