BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICOTEC ANTERIOR CERVICAL PLATE, 3 SEGMENTAL, 61 MM

    MDR report key: 20744994 · Received November 21, 2024

    Report

    Report Number
    3006493760-2024-00004
    Event Type
    Injury
    Date Received
    November 21, 2024
    Date of Event
    October 23, 2024
    Report Date
    November 21, 2024
    Manufacturer
    ICOTEC AG
    Product Code
    KWQ
    UDI-DI
    07640140438320
    PMA / PMN Number
    K233215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS OF THE RELEVANT PRODUCTION RECORDS DID NOT IDENTIFY ANY ANOMALIES THAT COULD BE A CAUSE OF THE EVENT. INVESTIGATION OF HISTORICAL ADVERSE EVENT DATA DETERMINED THAT ICOTEC HAS NOT BECOME AWARE OF ANY SIMILAR EVENTS WITH THIS DEVICES TO DATE. THE INVESTIGATION FINDINGS LEAD TO THE CONCLUSION THAT THE DEVICES DID NOT MALFUNCTION. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION OF THE CAUSE OF THIS EVENT. BASED ON THE INFORMATION AVAILABLE, NO CORRECTIVE ACTIONS ARE PROPOSED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    A PATIENT WAS TREATED WITH AN ICOTEC KONG-C VBR IN A SURGERY ON (B)(6) 2024 IN SWITZERLAND. FOR ANTERIOR STABILISTAION AN ICOTEC ANTERIOR CERVICAL PLATE WAS USED. SOME DAYS LATER (DATE NOT REPORTED TO MANUFACTURER), IT WAS DETECTED THAT THE ANTERIOR CERVICAL PLATE HAS COME LOOSE CAUDALLY. A REVISION SURGERY HAD TO BE CARRIED OUT ((B)(6) 2024). A NEW KONG-C VBR WAS IMPLANTED AND THE ANTERIOR CERVICAL PLATE WAS REPLACED WITH A LONGER PLATE AND FIXATED WITH MORE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2427328 ICOTEC ANTERIOR CERVICAL PLATE, 3 SEGMENTAL, 61 MM ICOTEC ANTERIOR CERVICAL PLATE, 3 SEGMENTAL, 61 MM KWQ ICOTEC AG 12-73-18-61 20/02 07640140438320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention