BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIOFIBER COMPRESSION STAPLE SYSTEM 20X20MM

    MDR report key: 19173231 · Received April 24, 2024

    Report

    Report Number
    3014554088-2024-00006
    Event Type
    Injury
    Date Received
    April 24, 2024
    Date of Event
    March 26, 2024
    Report Date
    April 24, 2024
    Manufacturer
    OSSIO LTD.
    Product Code
    MNU
    UDI-DI
    07290017630700
    PMA / PMN Number
    K212594
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY WAS NOTIFIED OF A SCHEDULED REMOVAL SURGERY FOLLOWING LOCALIZED PAIN IN THE OPERATED LEFT FOOT A YEAR AFTER IMPLANTATION. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. AN INVESTIGATION WAS PERFORMED INCLUDING INTERNAL ANALYSIS OF RECORDS, PATIENT IMAGING, LAB WORK AND SURGEON FEEDBACK. THERE IS NO INDICATION OF A DESIGN, MANUFACTURING, STERILIZATION, OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS. THERE WERE NO ISSUES DURING THE PRIMARY PROCEDURE. PATIENT POST OP RECOVERY WAS UNEVENTFUL, AND BONE HEALING AND FUSION OF THE OPERATED SITES WAS ACHIEVED. IMAGING DUE TO THE REPORTED PAIN REVEALED LOCALIZED BONE EDEMA. INFECTION WAS RULED OUT BY THE LAB WORK, NEGATIVE CULTURE, AND TIMING OF SYMPTOMS. THE INVESTIGATION CONCLUDED THAT THE ROOT CAUSE OF THE PAIN COULD NOT BE DETERMINED BUT IS LIKELY THE OUTCOME OF THE PATIENT EXPERIENCING A LOCAL REACTION TO ONE OF THE IMPLANT'S MATERIALS OR RELATED TO AN UNREPORTED UNDERLYING MEDICAL CONDITION. INSTRUCTIONS FOR USE LIST AN ALLERGIC REACTION AS A POTENTIAL ADVERSE EFFECT TO IMPLANTATION OF FOREIGN MATERIAL. COMPANY CONTINUES TO MONITOR THESE EVENTS AS PART OF POST MARKET ACTIVITIES. ADDITIONAL REPORTS RELATING TO THIS EVENT: # 3014554088-2024-00003/4/5 & 3014323288-2024-00003/4/5/6.

    Description of Event or Problem · 0

    PAIN AND LOCALIZED BONE EDEMA IN THE LEFT FOOT FOLLOWING A BUNION DEFORMITY CORRECTION. FOUR IMPLANTS WERE REMOVED ONE YEAR POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1329183 OSSIOFIBER COMPRESSION STAPLE SYSTEM 20X20MM STAPLE, ABSORBABLE MNU OSSIO LTD. OF2062020S OF02229 07290017630700

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Required Intervention OSSIOFIBER COMPRESSION SCREW 3.5X22MM| OSSIOFIBER COMPRESSION SCREW 3.5X24MM| OSSIOFIBER COMPRESSION SCREW 4.0X38MM