BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSIOFIBER COMPRESSION STAPLE SYSTEM

    MDR report key: 19255259 · Received May 6, 2024

    Report

    Report Number
    3014554088-2024-00010
    Event Type
    Injury
    Date Received
    May 6, 2024
    Date of Event
    April 1, 2024
    Report Date
    May 6, 2024
    Manufacturer
    OSSIO LTD.
    Product Code
    MNU
    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 RIGHT FOOT 8 MONTHS AFTER IMPLANTATION. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT ALSO HAD FOUR IMPLANTS REMOVED FROM THE LEFT FOOT A MONTH EARLIER DUE TO SIMILAR SYMPTOMS. AN INVESTIGATION WAS PERFORMED INCLUDING INTERNAL ANALYSIS OF RECORDS, SURGEON FEEDBACK, AND ANALYSIS OF SYMPTOMS. 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 WERE ACHIEVED. BASED ON THE SIMILARITY OF THE SYMPTOMS EXHIBITED IN THE RIGHT FOOT AND IN THE LEFT FOOT IT WAS CONCLUDED THAT THE ROOT CAUSE IS LIKELY THE SAME. THE INVESTIGATION OF THE LEFT FOOT EVENT RULED OUT INFECTION BASED ON IMAGING, LAB WORK, NEGATIVE CULTURES AND TIMING OF SYMPTOMS, AND 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: # 3014554088-2024-00007/8/9 & 3014323288-2024-00007/8/9/10. ADDITIONAL REPORTS RELATING TO THE LEFT FOOT OF THE SAME PATIENT: # 3014554088-2024-00003/4/5/6 & 3014323288-2024-00003/4/5/6.

    Description of Event or Problem · 0

    PAIN IN THE RIGHT FOOT FOLLOWING A BUNION DEFORMITY CORRECTION. FOUR IMPLANTS WERE REMOVED 8 MONTHS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614079 OSSIOFIBER COMPRESSION STAPLE SYSTEM STAPLE, ABSORBABLE MNU OSSIO LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Female Required Intervention OSSIOFIBER COMPRESSION SCREW 3.5X20MM.| OSSIOFIBER COMPRESSION SCREW 4.0X32MM.| OSSIOFIBER COMPRESSION SCREW 4.0X38MM.