BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INION FREEDOMSCREW

    MDR report key: 20094770 · Received August 29, 2024

    Report

    Report Number
    3003407235-2024-00005
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    November 6, 2023
    Report Date
    August 28, 2024
    Manufacturer
    INION OY
    Product Code
    HWC
    PMA / PMN Number
    K123672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE INCIDENT WAS ANALYSED BY THE CUSTOMER TO BE THE PATIENT'S OWN CAUSE DUE TO POOR SKIN CONDITION, ANAEMIA AND HYPOPROTEINAEMIA. BASED ON INFORMATION RECEIVED BY THE MANUFACTURER, IT IS PROBABLE THAT THE PROBLEMS WITH THE WOUND HEALING HAVE BEEN CAUSED/AFFECTED BY THE PATIENT CONDITIONS INCLUDING POOR SKIN CONDITION, ANEMIA, AND HYPOPROTEINEMIA. THE COMBINED EFFECTS CAN SIGNIFICANTLY IMPAIR WOUND HEALING. THE PATIENT UNDERWENT DEBRIDEMENT AND PRP IMPLANTATION TO IMPROVE WOUND HEALING AND RECEIVED FURTHER TREATMENT AT (B)(6) SURGERY DEPARTMENT. ACCORDING TO LONG TERM PMS DATA OF INION FREEDOM/OTPS SYSTEM (2004-2023) A COMPLICATION-TO OPERATION RATIO FOR A SHORT TERM FOREIGN BODY REACTION < 3 MONTHS POST-OPERATIVELY IS 0,01 % AND FOR AN INFECTION: 0,00 %. IT WAS VERIFIED THAT THERE ARE NO OTHER COMPLAINTS RELATED TO THIS LOT. BATCH RECORD REVIEW SHOWS THAT THERE ARE NO NONCONFORMITIES RELATED TO THE MANUFACTURE OR STERILIZATION OF THIS LOT. EVEN THOUGH THE PATIENT CONDITION DESCRIBED ABOVE IS LIKELY TO HAVE CAUSED THE PROBLEMS WITH THE WOUND HEALING, AND NO EVIDENCE HAVE BEEN RECEIVED BY INION THAT THE PROBLEM WOULD BE ASSOCIATED WITH INION IMPLANTS, THE INVOLVEMENT OF THE INION IMPLANT IN THE INCIDENT CANNOT BE UNDOUBTEDLY EXCLUDED WITH THE INFORMATION RECEIVED. THUS THIS COMPLAINT IS BEING REPORTED OUT OF AN ABUNDANCE OF CAUTION. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE.

    Description of Event or Problem · 0

    A 51-YEAR OLD FEMALE PATIENT WAS TREATED SURGICALLY FOR A DISTAL TIBIA FRACTURE. THE FRACTURE WAS FIXED WITH A BONE GRAFTING PLATE AND RESORBABLE SCREWS. BASED ON INFORMATION RECEIVED, NO INTRAOPERATIVE PROBLEMS WERE ENCOUNTERED, HOWEVER A DISPOSABLE SILICONE DRAIN WAS PLACED AFTERWARDS. POSTOPERATIVELY THE PATIENT FOUND THAT THE WOUND HEALED POORLY. THE PATIENT UNDERWENT DEBRIDEMENT AND PRP (PLATELET-RICH PLASMA) IMPLANTATION 1 MONTH POSTOPERATIVELY, NO IMPLANT REMOVAL HAS BEEN REPORTED. AFTER DEBRIDEMENT AND PRP THE WOUND STILL HEALED POORLY, AND THE PATIENT WAS THEN TRANSFERRED TO BONE MICROPROSTHETIC SURGERY DEPARTMENT FOR FURTHER TREATMENT. AT THE DISCHARGE TIME THE PATIENT PRESENTED ANAEMIA AND HYPOPROTEINAEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1523002 INION FREEDOMSCREW BONE SCREW HWC INION OY OSC-4555 2306024

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Female Required Intervention BONE GRAFTING PLATE