BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSSIOFIBER COMPRESSION SCREW 4.0 MM

    MDR report key: 17850906 · Received October 2, 2023

    Report

    Report Number
    3014554088-2023-00002
    Event Type
    Malfunction
    Date Received
    October 2, 2023
    Date of Event
    August 21, 2023
    Report Date
    October 2, 2023
    Manufacturer
    OSSIO LTD.
    Product Code
    HWC
    PMA / PMN Number
    K193660
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMPANY WAS INFORMED OF A PATIENT WITH BROKEN IMPLANTS 6-WEEKS FOLLOWING A CORRECTION OF HALLUX VALGUS WITHOUT FUSION/OSTEOTOMY. BREAKAGE WAS CONFIRMED BY CT, BUT NO IMAGING WAS PROVIDED TO THE COMPANY. NO INFORMATION ON POST-OP INSTRUCTIONS, OR POST-OP IMMOBILIZATION REGIME WAS PROVIDED. NO IMPLANTS REMOVAL OR REVISION SURGERY HAS BEEN DONE. THE ACTUAL DEVICES COULD NOT BE EXAMINED AS THEY WERE NOT PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE. BASED ON THE REVIEW OF CURRENTLY AVAILABLE INFORMATION THE COMPANY HAS NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY SPECIFICATIONS; THE COMPANY IS UNABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE. THE INSTRUCTIONS FOR USE INCLUDE PRECAUTIONS AND RECOMMENDATIONS FOR THE SELECTION OF APPROPRIATE SURGICAL TECHNIQUE, IMPLANT SIZE, CONFIGURATION, SURGICAL SITE PREPARATION, AND INSTRUCTS THAT THE PATIENT IS WARNED THAT THE DEVICE MIGHT BREAK OR BE DAMAGED AS A RESULT OF EARLY WEIGHT BEARING OR EXCESSIVE ACTIVITY. IT ALSO EMPHASIZES THE IMPORTANCE OF CORRECT PATIENT SELECTION AND CONTRAINDICATES USE IN PATIENTS WHERE POST-OP COMPLIANCE CANNOT BE GUARANTEED. BECAUSE THE COMPANY CANNOT RULE OUT THE POSSIBLE CONTRIBUTION OF THE DEVICE TO THE EVENT, OUT OF AN ABUNDANCE OF CAUTION AND IN THE INTEREST OF COMPLIANCE, IT IS BEING REPORTED. COMPANY CONTINUES TO MONITOR THESE EVENTS AS PART OF POST MARKET ACTIVITIES. ADDITIONAL REPORTS RELATING TO THIS EVENT ARE:#3014554088-2023-00003 & #3014323288-2023-00002/3.

    Description of Event or Problem · 0

    REPORT OF IMPLANTS BREAKAGE 6-WEEKS FOLLOWING A CORRECTION OF HALLUX VALGUS USING A 4.0MM SCREW AND 3.0MM NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1341144 OSSIOFIBER COMPRESSION SCREW 4.0 MM SCREW, FIXATION, BONE HWC OSSIO LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female OSSIOFIBER TRIMMABLE FIXATION NAIL, CANNULATED 3MM.