BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIBFIX TITAN

    MDR report key: 23760854 · Received December 9, 2025

    Report

    Report Number
    3006981798-2025-00050
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    October 13, 2025
    Report Date
    December 9, 2025
    Manufacturer
    RIVERPOINT MEDICAL LLC
    Product Code
    HRS
    PMA / PMN Number
    K241282
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOLOGICAL EVALUATION REPORT AND RIBFIX TITAN FIXATION SYSTEM ADOPTION TESTING, IN-HOUSE STERILIZATION TEST REPORT WERE REVIEWED AND THERE WERE NO ISSUES NOTED, THIS TESTING HAS SHOWN THE PRODUCT TO CONTAIN SUBSTANTIALLY LESS NATURAL BIOBURDEN THAN THE PROCESS IS ROUTINELY CHALLENGED WITH, NOT TO EXERT BACTERIOSTATIC/FUNGISTATIC PROPERTIES AND TO MEET REQUIREMENTS FOR EO RESIDUALS, AND TO BE LESS RESISTANT TO EO STERILIZATION THAN THE VALIDATED PCD WHEN INOCULATED AT WORST-CASE LOCATIONS. THE REPORT COULD NOT BE SUBSTANTIATED. A CAUSE FOR THE EVENT CANNOT BE ESTABLISHED. THIS REPORT AND USE OF CATEGORICAL DEFINITIONS REQUIRED BY FDA 3500A DOES NOT CONSTITUTE AN ADMISSION BY RIVERPOINT MEDICAL OR ITS EMPLOYEES THAT RIVERPOINT MEDICAL OR ITS EMPLOYEES HAS CAUSE OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. RIVERPOINT MEDICAL FILED THIS INFORMATION TO COMPLY WITH THE MEDICAL DEVICE REPORTING REGULATION 21 CFR 803. IF ADDITIONAL INFORMATION IS PROVIDED TO RIVERPOINT MEDICAL REGARDING THIS EVENT, A SUPPLEMENTARY 3500A FORM WILL BE SUBMITTED AS REQUIRED BY FDA.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER: "DETAILS: · ORIGINAL IMPLANT DATE: (B)(6) 2025 - DR. (B)(6). PATIENT: 55-YEAR-OLD MALE. · PROCEDURE: LATERAL RIB FIXATION, RIBS 5-9. O RIB 5: TITAN INTRA 60 MM (3 ANCHORS). O RIB 6: TITAN INTRA 60 MM (2 ANCHORS). O RIB 7: TITAN INTRA 60 MM (2 ANCHORS). O RIB 8: TITAN INTRA 60 MM (2 ANCHORS). O RIB 9: TITAN INTRA 94 MM (4 ANCHORS). SUMMARY OF EVENT: THE PATIENT PRESENTED WITH ONGOING PAIN AND DISCOMFORT AND SUBSEQUENTLY TESTED POSITIVE FOR INFECTION. ON (B)(6) 2025, DR. (B)(6) RETURNED THE PATIENT TO THE OR FOR A CHEST WASHOUT AND ASSESSMENT FOR POTENTIAL HARDWARE REMOVAL. UPON ENTERING THE CHEST CAVITY, PURULENT FLUID WAS NOTED IN POCKETS BENEATH THE MUSCLE AND OVERLYING THE JUGGERKNOT ANCHORS ACROSS ALL PLATED LEVELS. AT RIB LEVEL 6, THE TITAN INTRA 60 MM BRIDGE WITH TWO ANCHORS WAS FOUND TO HAVE A JUGGERKNOT COMPLETELY DETACHED AND FLOATING BENEATH THE MUSCLE. BOTH WHITE AND BLUE SUTURES HAD PULLED THROUGH, AND THE BUTTON WAS NO LONGER ATTACHED (RETRIEVED SAFELY). DR. (B)(6) NOTED THIS MAY REPRESENT A POSSIBLE HARDWARE FAILURE. ALL REMAINING IMPLANTS WERE SUCCESSFULLY REMOVED AND SENT TO PATHOLOGY FOR EVALUATION." "WE DO NOT HAVE LOT NUMBERS. ETIOLOGY OF INFECTION UNKNOWN. NOT KNOWN IF INFECTION CAUSED FAILURE BUT COULD BE PRESUMED IT HADSOME SORT OF IMPACT. NO IMAGES AVAILABLE.""

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2775173 RIBFIX TITAN 60MM INTRA PRE-BENT PLATE HRS RIVERPOINT MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization