BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATE-C

    MDR report key: 25299656 · Received May 27, 2026

    Report

    Report Number
    3027726367-2026-00000
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 1, 2026
    Report Date
    May 27, 2026
    Manufacturer
    HAPPE SPINE
    Product Code
    ODP
    PMA / PMN Number
    K222004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT DID NOT RESULT IN ANY PATIENT HARM, INJURY, OR SURGICAL DELAY. NEITHER THE DEVICE NOR THE INTEROPERATIVE PATIENT X-RAY FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, A DEFINITIVE CAUSE OF THE REPORTED EVENT IS UNABLE TO BE DETERMINED. BASED ON THE NARRATIVE PROVIDED BY THE DISTRIBUTOR REPRESENTATIVE PRESENT AT THE TIME OF THE EVENT, THE DEVICE MALFUNCTION MAY HAVE BEEN CAUSED BY A CANTILEVER FORCE APPLIED INTENTIONALLY OR UNINTENTIONALLY TO THE THREADED INSERTER HANDLE WHILE ATTACHED TO THE IMPLANT IN THE C6/7 DISC SPACE. THE SURGEON EVALUATED THE IMPLANTED DEVICE AND OBSERVED NO OTHER MALFUNCTION OF THE IMPLANT OR DETRIMENT TO THE SURGICAL OUTCOME. HAPPE SPINE HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AT THE TIME OF THE SUBMISSION DATE OF THIS REPORT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A DISTRIBUTOR REPRESENTATIVE REGARDING A PATIENT IMPLANTED WITH AN INTEGRATE-C DEVICE DURING ANTERIOR CERVICAL DISCECTOMY AND FUSION AT C4-7. AFTER INSERTING THE IMPLANT INTO THE DISC SPACE, A PORTION OF THE ANTERIOR THREADED REGION OF THE IMPLANT WAS REPORTED TO REMAIN ATTACHED TO THE THREADED INSERTER HANDLE UPON ITS REMOVAL FROM THE IMPLANT. THE SURGEON ELECTED TO LEAVE THE IMPLANT IN SITU AFTER CAREFUL EVALUATION OF THE IMPLANT PLACEMENT, STABILITY, AND RESTORATION OF DISC HEIGHT. 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
    484031 INTEGRATE-C Intervertebral fusion device with bone graft, cervical ODP HAPPE SPINE 8H2AF07M07 IC4145

    Patients

    Seq Age Sex Outcome Treatment
    1