BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CETRA

    MDR report key: 17765546 · Received September 18, 2023

    Report

    Report Number
    2183449-2023-00004
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 17, 2023
    Report Date
    August 18, 2023
    Manufacturer
    ORTHOFIX MEDICAL INC
    Product Code
    KWQ
    UDI-DI
    18257200120314
    PMA / PMN Number
    K162638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE INVOLVED IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED.A REVIEW OF THE DEVICE HISTORY RECORD FOR CETRA PLATE PART NUMBER 19-0124, LOT E31 WAS PERFORMED WHICH RESULTED IN NO ANOMALIES IN THE DEVICE.

    Description of Event or Problem · 0

    INFORMATION PROVIDED STATES THAT THE PATIENT UNDERWENT AN ACDF, ANTERIOR CERVICAL DISCETOMY AND FUSION, SURGERY ON (B)(6), 2023. ADDITIONAL INFORMATION PROVIDED ON SEPTEMBER 1, STATES THAT THE SURGERY WAS SCHEDULED AS A 360 DEG PROCEDURE PERFORMING BOTH ANTERIOR AND POSTERIOR FUSION. DURING THE ANTERIOR PORTION OF THE SURGERY, AFTER SEATING THE PLATE, THE SURGEON ATTEMPTED TO REDUCE A LISTHESIS WHEN ONE OF THE PEDICAL SCREWS PULLED THROUGH THE PLATE. THE SCREW AND PLATE REMAIN IMPLANTED. A SECONDARY SURGERY IS REQUIRED TO COMPLETE THE POSTERIOR SEGMENT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269139 CETRA ANTERIOR CERVICAL PLATE KWQ ORTHOFIX MEDICAL INC E31 18257200120314

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other