BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPORE SURGICAL IMPLANT

    MDR report key: 12408172 · Received September 1, 2021

    Report

    Report Number
    3009383407-2021-00003
    Event Type
    Injury
    Date Received
    September 1, 2021
    Report Date
    September 1, 2021
    Manufacturer
    MATRIX SURGICAL USA
    Product Code
    FZD
    UDI-DI
    00855421005284
    PMA / PMN Number
    K23908
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INITIAL REPORT, A PATIENT IS UNDERGOING A SURGERY REVISION DUE TO AN EAR IMPLANT FRACTURE. THE DATE OF THE SURGERY IS UNKNOWN. REQUESTS FOR ADDITIONAL INFORMATION WERE MADE TO NO AVAIL. AS THE LOT NUMBER OF THE PRODUCT IS UNKNOWN, MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL DETAILS WILL BE PROVIDED IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORT, THE SURGEON STATED THAT A PATIENT EXPERIENCED AN IMPLANT FRACTURE AND NEEDED A REPLACEMENT FOR SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302258 OMNIPORE SURGICAL IMPLANT EAR IMPLANT FZD MATRIX SURGICAL USA OP8330 00855421005284

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R