BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPORE SURGICAL IMPLANT

    MDR report key: 16278757 · Received February 1, 2023

    Report

    Report Number
    3009383407-2022-00002
    Event Type
    Injury
    Date Received
    February 1, 2023
    Date of Event
    November 21, 2022
    Report Date
    December 21, 2022
    Manufacturer
    MATRIX SURGICAL USA
    Product Code
    FZD
    UDI-DI
    00855421005413
    PMA / PMN Number
    K123908
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS FOR ADDITIONAL INFORMATION WERE MADE TO NO AVAIL. THE PRODUCT WAS NOT RETURNED FOR FURTHER EVALUATION. THE LOT NUMBER WAS TRACED, AND A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES IDENTIFIED DURING THE PROCESSING OF THE IMPLANT. A REVIEW OF THE STERILITY RESULTS WAS CONDUCTED. ALL STERILITY SPECIFICATIONS MET REQUIREMENTS UPON PRODUCT RELEASE. BASED ON THE INFORMATION PROVIDED, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. A REVIEW OF THE RISK ANALYSIS WAS PERFORMED. NON-STERILE PRODUCTS ARE LISTED AS A SERIOUS HAZARD. THE STERILITY CYCLE PARAMETERS MUCH BE MET AS WELL AS THE VOLUME OF PYROGENS ON THE DEVICE. IN THIS CASE, ALL STERILITY PARAMETERS WERE MET AND THE PYROGEN RESULTS WERE WELL WITHIN RANGE. CONCLUSIVELY, INFECTION IS A KNOWN INHERENT RISK OF ANY SURGICAL PROCEDURE. THE INSTRUCTIONS FOR USE LIST SUPERFICIAL AND/OR DEEP INFECTION AS A POSSIBLE EFFECT.

    Additional Manufacturer Narrative · 0

    THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, A MICROTIA PATIENT HAD SURGERY ON (B)(6) 2022 AND NOW HAS A FUNGAL INFECTION OF HIS IMPLANT. THE PATIENT WILL UNDERGO SURGICAL REVISION.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORT, A MICROTIA PATIENT HAD SURGERY ON (B)(6) 2022 AND NOW HAS A FUNGAL INFECTION OF HIS IMPLANT. THE PATIENT WILL UNDERGO SURGICAL REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403805 OMNIPORE SURGICAL IMPLANT FACIAL IMPLANT FZD MATRIX SURGICAL USA 89021 007020922 00855421005413

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Hospitalization| R