BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PD-31-203

    MDR report key: 20798068 · Received November 27, 2024

    Report

    Report Number
    3009394448-2024-00006
    Event Type
    Injury
    Date Received
    November 27, 2024
    Date of Event
    November 1, 2024
    Report Date
    November 25, 2024
    Manufacturer
    PROVIDENCE MEDICAL TECHNOLOGY, INC
    Product Code
    ODP
    PMA / PMN Number
    K122801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    THE INDEX PROCEDURE WAS A SINGLE CAGE PLACED AT C6-C7 USING PD-31-203 CERVICAL CAGE-X, 4MM. PROVIDENCE MEDICAL TECHNOLOGY WAS NOTIFIED THAT A REVISION PROCEDURE OCCURRED ON (B)(6) 2024, TO REMOVE THE IMPLANT CAGE. THE SURGEON STATED THAT THE CAGES WERE MALPOSITIONED IN THE INDEX PROCEDURE. THERE WAS NO DEVICE MALFUNCTION, AND REMOVAL WAS NOT DUE TO THE FAILURE OF THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843699 PD-31-203 Intervertebral fusion device with bone graft, cervical ODP PROVIDENCE MEDICAL TECHNOLOGY, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention