BEUDAMED
    FDA Adverse Event Injury Summary report: N

    18.0MM ACUTRAK® FUSION DEVICE

    MDR report key: 15764964 · Received November 9, 2022

    Report

    Report Number
    3025141-2022-00372
    Event Type
    Injury
    Date Received
    November 9, 2022
    Date of Event
    October 18, 2022
    Report Date
    November 9, 2022
    Manufacturer
    ACUMED, LLC
    Product Code
    HWC
    PMA / PMN Number
    K930834
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AS IT WAS IMPLANTED IN THE PATIENT. MANUFACTURING AND INSPECTION RECORDS WERE REVIEWED, AND NO ANOMALIES WERE FOUND. MANUFACTURING RECORDS CONFIRM THE EXPIRATION DATE OF THE PRODUCT WAS 04 OCTOBER 2022. BASED ON THE INFORMATION RECEIVED, THE FACILITY IMPLANTED EXPIRED PRODUCT IN THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE FACILITY IMPLANTED A SCREW IN THE PATIENT, AND THE SCREW HAD EXPIRED ON (B)(6) 2022. IT WAS REPORTED A FIELD REPRESENTATIVE HAD NOT BEEN CONTACTED FOR THE PROCEDURE AND THEREFORE, HAD NOT BEEN PRESENT DURING THE PROCEDURE. THE FACILITY HAD OPENED CONSIGNED IMPLANTS ON THEIR OWN, AND THE EXPIRED PRODUCT WAS DUE TO BE RETURNED TO ACUMED, LLC IN THE MONTH OF OCTOBER. ATTEMPTS WERE MADE TO DETERMINE THE STATUS OF THE PATIENT; HOWEVER, THESE ATTEMPTS WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2419401 18.0MM ACUTRAK® FUSION DEVICE SCREW, FIXATION, BONE HWC ACUMED, LLC ATF-180-S 361475

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other