BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUZEFIX MINI SCREW

    MDR report key: 20480242 · Received October 17, 2024

    Report

    Report Number
    MW5161189
    Event Type
    Injury
    Date Received
    October 17, 2024
    Date of Event
    March 9, 2024
    Report Date
    November 11, 2024
    Manufacturer
    FUSION ORTHOPEDICS USA, LLC.
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR REPORT MW5161189 ON 11/13/2024; 1 MONTH POST IMPLANT ((B)(6) 2024) THE PATIENT DEVELOPED SEVERE ITCHING AND HIVES. HIVES APPEARED ON UPPER PART OF THE BODY. ECZEMA DEVELOPED AND CHRONIC INFLAMMATORY SKIN CONDITIONS PERSISTED AND EXPANDED OVER HIS ENTIRE BODY. NUMEROUS VISITS AND EMAILS TO PRIMARY CARE, 2 ALLERGISTS AND DERMATOLOGY BEGINNING IN (B)(6) 2024. PATIENT STARTED ON XOLAIR FOR HIVES (B)(6) 2024 AND CONTINUES ON THIS THERAPY. PATIENT HAS BEEN ON STEROID CREAM FOR ECZEMA AND CONTINUES ON THIS THERAPY. PATIENT REQUESTS THAT THIS BE REPORTED AND INVESTIGATED AS A POTENTIAL ALLERGIC REACTION TO THE IMPLANT SCREWS WHICH ARE TITANIUM ALLOY (TI6AL4V), ALTHOUGH ITS NOT CLEAR IF THERE WAS ANY PROBLEM OR ISSUE WITH THE DESIGN OR MANUFACTURE OF THE DEVICE ITSELF. PATIENT HAS POSSESSION OF THE REMOVED IMPLANTS. THERE WAS OTHER HARDWARE FROM ANOTHER COMPANY WHICH WAS PLACED ON THE LEFT LATERAL ANKLE. ON NOVEMBER 11, THE 30-DAY RESPONSE IS BEING SUBMITTED. 30 DAY REPORTER: (B)(6), TITLE: QUALITY ENGINEER. REFERENCE REPORTS MW5161186, MW5161187, MW5161188.

    Description of Event or Problem · 0

    PATIENT HAD A LOCKING FIBULA PLATE AND SCREWS PLACED ON (B)(6) 2024 RESULTING FROM A BROKEN ANKLE. THE IMPLANTS WERE REMOVED (B)(6) 2024 DUE TO SOME SORT OF ALLERGIC REACTION/IMMUNE RESPONSE. ORIF SURGERY: PATIENT NAME - (B)(6), DATE OF SURGERY - (B)(6) 2024, SURGEON - (B)(6), HOSPITAL / FACILITY - (B)(6); VI HARDWARE REMOVAL SURGERY: DATE OF REMOVAL - (B)(6) 2024, SURGEON - (B)(6) HOSPITAL / FACILITY - (B)(6) HOSPITAL, (B)(6); REASON FOR REMOVAL - POTENTIAL SYSTEMIC ADVERSE REACTION TO THE HARDWARE. ONE MONTH POST IMPLANT (B)(6) THE PATIENT DEVELOPED SEVERE ITCHING AND HIVES. SUBSEQUENTLY ECZEMA DEVELOPED AND CHRONIC INFLAMMATORY SKIN CONDITIONS PERSISTED AND EXPANDED OVER HIS ENTIRE BODY. PATIENT REQUESTS THAT THIS BE REPORTED AND INVESTIGATED AS A POTENTIAL ALLERGIC REACTION TO THE IMPLANT SCREWS WHICH ARE TITANIUM ALLOY (B)(4), ALTHOUGH ITS NOT CLEAR IF THERE WAS ANY PROBLEM OR ISSUE WITH THE DESIGN OR MANUFACTURE OF THE DEVICE ITSELF. PATIENT HAS POSSESSION OF THE REMOVED IMPLANTS. REF REPORTS: MW5161186, MW5161187, MW5161188.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 12/31/2024 FOR MW5161189. THIS IS A RESPONSE TO MDR REPORT #MW5161189. SINCE THE PRIOR SUBMITTED MDR REPORT, THERE HAS BEEN NO NEW INFORMATION RECEIVED. FUSION HAS MADE SEVERAL ATTEMPTS TO CONTACT BOTH HOSPITALS (HOSPITAL WHERE SCREW WAS FIRST IMPLANTED: (B)(6) MEDICAL CENTER, AND HOSPITAL WHERE SCREW WAS REMOVED: (B)(6) HOSPITAL) BUT NEVER RECEIVED NEITHER EMAILS OR CALL BACKS. VARIOUS CALLS WERE MADE ON: 12/11/2024, 12/16/2024, 12/19/2024, AND 12/20/2024. NO INFORMATION WAS RECEIVED. THIS WILL BE THE FINAL FOLLOW UP TO THE MDR ISSUED TO FUSION UNLESS THERE IS FUTURE INFORMATION FOR FUSION TO REPORT ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208972 FUZEFIX MINI SCREW SCREW, FIXATION, BONE HWC FUSION ORTHOPEDICS USA, LLC. FX-HD-4040

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other VINCRISTINE.