BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERIFIXX SMALL BONE IMPLANT

    MDR report key: 12225722 · Received July 23, 2021

    Report

    Report Number
    MW5102757
    Event Type
    Injury
    Date Received
    July 23, 2021
    Date of Event
    March 3, 2021
    Report Date
    July 21, 2021
    Manufacturer
    ARMIS BIOPHARMA, INC.
    Product Code
    HTY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    QUALITY CHECK CONFIRMED NO PROBLEMS DURING MANUFACTURING PROCESS, DISTRIBUTED APPROPRIATELY, AND STORED ACCURATELY. DR. (B)(6) WAS AWARE THAT THE PATIENT WAS NOT COMPLYING WITH THE INSTRUCTION TO STAY OFF OF HER FOOT THE WEEK AFTER THE IMPLANT WHEN SHE VISITED DR. (B)(6) OFFICE FOR POST PROCEDURE OFFICE VISIT. PATIENT CONTINUED TO WALK EXTENSIVELY ON HER FOOT. RELEVANT DATES BELOW: DATE OF SURGERY: (B)(6) 2021, FIRST POST OP VISIT: (B)(6) 2021 (PATIENT NOT COMPLIANT; BANDAGE NOT ON TOE). SECOND POST OP VISIT (B)(6) 2021 (PATIENT STILL NOT COMPLIANT; STITCHED REMOVED; TOE RE-BANDAGED. THIRD POST OP VISIT (B)(6) 2021 (WOUND IS OPEN; DR. (B)(6) SUSPECTS IMPLANT SEPARATION AND SCHEDULES PATIENT FOR EXPLANT, IMPLANT REMOVED AND REPLACED WITH K-WIRE). AS (B)(6) 2021 PATIENT HAS MADE FULL RECOVERY. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118518 VERIFIXX SMALL BONE IMPLANT PIN, FIXATION, SMOOTH HTY ARMIS BIOPHARMA, INC. HTASSY4-CR 24310062101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention