BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSFERION

    MDR report key: 25011412 · Received April 28, 2026

    Report

    Report Number
    3007738819-2026-00004
    Event Type
    Injury
    Date Received
    April 28, 2026
    Date of Event
    June 5, 2023
    Report Date
    April 28, 2026
    Manufacturer
    OSFERIONBIOMATERIALS CORP. MISHIMA FACTORY
    Product Code
    MQV
    UDI-DI
    04560245656913
    PMA / PMN Number
    K080065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION RECEIVED FROM ARTHREX, INC., INCLUDING THEIR MEDICAL DEVICE REPORT, INITIAL REPORT, AND FOLLOW-UP REPORTS, THE COMPLAINT ALLEGATION REGARDING BREAKAGE OF SCREWS WAS CONFIRMED, AND IT WAS CONCLUDED THAT THE MOST LIKELY CAUSE OF THE REPORTED FAILURE WAS ATTRIBUTABLE TO A PATIENT-SPECIFIC FACTOR. THREE (3) "OSFERION" (AR-13370-4) MANUFACTURED BY OUR COMPANY WERE USED AS A BONE VOID FILLER AND WERE NOT LOAD-BEARING FIXATION DEVICES. THERE WAS NO EVIDENCE REPORTED INDICATING BREAKAGE, MALFUNCTION, OR PERFORMANCE FAILURE OF OSFERION. AT THIS TIME, THERE IS NO INFORMATION AVAILABLE TO SUGGEST THAT OUR DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE RECEIVED THE INFORMATION FROM ARTHREX, INC., ON (B)(6) 2026. THIS REPORT IS BEING SUBMITTED TO FDA TO DOCUMENT THAT OUR COMPANY BECAME AWARE OF THE ADVERSE EVENT INVOLVING THE USE OF OUR DEVICE IN CONJUNCTION WITH OTHER MANUFACTURERS' FIXATION COMPONENTS.

    Description of Event or Problem · 0

    BASED ON INFORMATION PROVIDED BY ARTHREX, INC., IT WAS REPORTED THAT DURING A HIGH TIBIAL OSTEOTOMY PROCEDURE, ARTHREX, INC.- MANUFACTURED CANCELLOUS SCREWS WERE FOUND BROKEN DURING A POST-OPERATIVE FOLLOW-UP. THE PATIENT HAS COMPLAINED OF A SENSATION OF INSTABILITY BUT DOES NOT REPORT A SPECIFIC EVENT OR TIME FRAME IN WHICH THE INSTABILITY STARTED. THREE (3) AR-13370-4 "OSFERION" (OSTEOTOMY WEDGES) MANUFACTURED BY OUR COMPANY WERE ALSO IMPLANTED DURING THE SAME PROCEDURE. REVISION SURGERY WAS SUBSEQUENTLY PERFORMED, DURING WHICH THE BROKEN SCREWS AND ASSOCIATED IMPLANTED COMPONENTS, INCLUDING THE THREE (3) AR-13370-4 "OSFERION" (OSTEOTOMY WEDGES), WERE EXPLANTED. THE ORIGINAL PROCEDURE OCCURRED ON (B)(6) 2022, AND REVISION SURGERY OCCURRED ON (B)(6) 2023. BOTH THE INITIAL PROCEDURE AND THE REVISION SURGERY WERE PERFORMED AT THE SAME FACILITY BY THE SAME SURGEON. ACCORDING TO THE INFORMATION RECEIVED, POST-OPERATIVE X-RAY IMAGES WERE REVIEWED AS PART OF THE EVALUATION BY ARTHREX, INC., AND BASED ON THE INFORMATION AVAILABLE, THE EVENT WAS CONCLUDED TO BE MOST LIKELY ATTRIBUTABLE TO A PATIENT-SPECIFIC FACTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1071841 OSFERION FILLER, BONE VOID, CALCIUM COMPOUND, PRODUCT CODE: MQV MQV OSFERIONBIOMATERIALS CORP. MISHIMA FACTORY UNKNOWN 04560245656913

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization