BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOFUSE TALAR SCREW

    MDR report key: 22554145 · Received July 21, 2025

    Report

    Report Number
    3010470557-2025-06021
    Event Type
    Injury
    Date Received
    July 21, 2025
    Date of Event
    April 14, 2022
    Report Date
    August 11, 2025
    Manufacturer
    IN2BONES SAS
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ON-GOING. THIS REPORT IS AN INITIAL ONE, A FINAL REPORT WILL BE SUBMITTED LATER ONCE ALL INVESTIGATIONS ARE COMPLETED.

    Additional Manufacturer Narrative · 0

    NOT ENOUGH INFORMATION ARE PROVIDED TO QUESTIONED THE DESIGN OF THE NEOFUSE IMPLANT. MOREOVER, THE BONE DISEASE OF THE PATIENT COULD EXPLAIN THE NON UNION OF THE IMPLANT. THEN, ACCORDING THE EVENT'S DESCRIPTION, THIS NON UNION LEAD TO THE SCREW BREAKAGE. ALSO, THE DESIGN IS NOT QUESTIONED. INFORMATION SHARED BY THE SURGEON ON (B)(6) 2025 ENABLES TO KNOW THAT: THE PATIENT AS A POOR BONE QUALITY (BONE DISEASE: ELHER DENLOS-TYPE). THE ADVERSE EFFECT MENTIONED (NON-UNION) IS NOT DUE TO THE IMPLANT (NO IMPLANT FAILURE) AS MENTIONED ABOVE, THE BONE DISEASE COULD EXPLAIN THE PSEUDOARTHROSIS OBSERVED DURING THE POST OPERATION CHECK. MOREOVER, THE PATIENT'S DEATH IS NOT RELATED TO THE NEOFUSE ANKLE FUSION PLATE IMPLANT AND TO THE SURGERY. THE SIDE EFFECTS (NON-UNION AND SCREW BREAKAGE) IS MENTIONED IN THE IFU022 REVISION 3 ON (B)(6) 2022 FOR NEOFUSE ANKLE FUSION, PARAGRAPH 5 "COMPLICATIONS": "COMPLICATIONS MAY INCLUDE BUT ARE NOT LIMITED TO, BENDING, LOOSENING AND/OR BREAKAGE, DELAYED UNION OR PSEUDOARTHROSIS." THEN, IN THIS IFU, IT IS MENTIONED IN PARAGRAPH 3 "CONTRAINDICATIONS" THAT "THE IMPLANT SHOULD NOT BE USED IN A PATIENT WHO HAS CURRENTLY, OR WHO HAS HISTORY OF, BONE PATHOLOGIES THAT MAY COMPROMISE THE RIGIDITY OF THE IMPLANT FIXATION (EXAMPLES INCLUDE: OSTEOPOROSIS, ACUTE CYSTIC DEVELOPMENTS, ACUTE OSTEOPENIA, BONE TUMOR, ETC.)". EVENTS DESCRIBED IN THIS COMPLAINT ARE MENTIONED IN THE IFU. TO CONCLUDE, INVESTIGATION OF THIS EVENT SHOWS THAT: BATCH RECORD CANNOT BE REVIEWED, THE DEVICE IS NOT AVAILABLE AND NO PICTURE WAS SHARED, DELAYED UNION OR PSEUDARTHROSIS ARE MENTIONED IN THE IFU, PATIENT HAS A BONE DISEASE, THIS IS A CONTRAINDICATION MENTIONED IN THE IFU, ADVERSE EFFECT ISN'T DUE TO THE NEOFUSE ANKLE FUSION PLATE IMPLANT. THE ROOT CAUSE OF THE EVENT IS PATIENT RELATED: POOR BONE QUALITY.

    Description of Event or Problem · 0

    THE IN2BONES NEOFUSE® ARTHRODESIS PLATING SYSTEM IMPLANTS ARE INTENDED TO BE USED FOR ANTERIOR FIXATION OF THE ANKLE ARTHRODESIS AND FRACTURES, INCLUDING THE DISTAL TIBIA, TALUS AND CALCANEUS. THE NEOFUSE® ARTHRODESIS PLATING SYSTEM IS INDICATED IN PRIMARY OR REVISION SURGERY FOR PATIENTS WITH: - PRIMARY OSTEOARTHRITIS. - POST-TRAUMATIC OSTEOARTHRITIS. - SECONDARY OSTEOARTHRITIS. DURING A 12-MONTH FOLLOW-UP VISIT (ON (B)(6) 2022) FOLLOWING AN OPERATION PERFORMED ON (B)(6) 2021 FOR THE INSERTION OF A NEOFUSE PLATE, THE SURGEON NOTICED A NON-UNION FOLLOWING THE BREAKAGE OF THE TALUS SCREW. THIS WAS ONLY SEEN ON (B)(6) 2025 AS PART OF A PMCF PROSPECTIVE STUDY DATE REVIEW FOR THE NEOFUSE PRODUCT (ANONYMIZED PATIENT: FPA, SITE 1). SURGERY REVISION HAPPENED ON (B)(6) 2023. THE PATIENT IS LISTED IN THE DATABASE AS DECEASED, WITH NO FURTHER INFORMATION AND NO INDICATION OF WHETHER THE PRODUCT IS RELATED. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 18TH 2025 FROM DR (B)(6) (SURGEON PARTICIPATING OF THE PMCF STUDY): "PATIENT FPA: ELHER DENLOS-TYPE BONE DISEASE. - NON-UNION NOTED 1 YEAR LATER. - REVISION SURGERY IN 2023, CONSOLIDATION, BUT REVISION NOT INCLUDED IN THE DATABASE. - NO IMPLANT FAILURE, BUT NON-UNION DUE TO POOR BONE QUALITY. - PATIENT DIED OF A RUPTURED AORTIC VALVE DUE TO HER COAGULOPATHY."

    Description of Event or Problem · 0

    THE IN2BONES NEOFUSE® ARTHRODESIS PLATING SYSTEM IMPLANTS ARE INTENDED TO BE USED FOR ANTERIOR FIXATION OF THE ANKLE ARTHRODESIS AND FRACTURES, INCLUDING THE DISTAL TIBIA, TALUS AND CALCANEUS. THE NEOFUSE® ARTHRODESIS PLATING SYSTEM IS INDICATED IN PRIMARY OR REVISION SURGERY FOR PATIENTS WITH: PRIMARY OSTEOARTHRITIS, POST-TRAUMATIC OSTEOARTHRITIS, SECONDARY OSTEOARTHRITIS. DURING A 12-MONTH FOLLOW-UP VISIT (ON (B)(6) 2022) FOLLOWING AN OPERATION PERFORMED ON (B)(6) 2021 FOR THE INSERTION OF A NEOFUSE PLATE, THE SURGEON NOTICED A NON-UNION FOLLOWING THE BREAKAGE OF THE TALUS SCREW. THIS WAS ONLY SEEN ON (B)(6) 2025 AS PART OF A PMCF PROSPECTIVE STUDY DATE REVIEW FOR THE NEOFUSE PRODUCT (ANONYMIZED PATIENT: FPA, SITE 1). SURGERY REVISION HAPPENED ON (B)(6) 2023. THE PATIENT IS LISTED IN THE DATABASE AS DECEASED, WITH NO FURTHER INFORMATION AND NO INDICATION OF WHETHER THE PRODUCT IS RELATED. ADDITIONAL INFORMATION WAS RECEIVED ON JULY 18TH 2025 FROM DR TOURNÉ (SURGEON PARTICIPATING OF THE PMCF STUDY): "PATIENT FPA: ELHER DENLOS-TYPE BONE DISEASE. NON-UNION NOTED 1 YEAR LATER. REVISION SURGERY IN 2023, CONSOLIDATION, BUT REVISION NOT INCLUDED IN THE DATABASE. NO IMPLANT FAILURE, BUT NON-UNION DUE TO POOR BONE QUALITY. PATIENT DIED OF A RUPTURED AORTIC VALVE DUE TO HER COAGULOPATHY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937961 NEOFUSE TALAR SCREW TALAR SCREW & CAP DIAM 3.5 HRS IN2BONES SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention