BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL SWISSPLUS OCTAGON 4. 1MM 12MM

    MDR report key: 9261236 · Received October 31, 2019

    Report

    Report Number
    0002023141-2019-01000
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Report Date
    December 31, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K011245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL SWISSPLUS OCTAGON 4. 1MM 12MM (OPB12) WAS RETURNED FOR INVESTIGATION WITHOUT ANY PACKAGING. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED NO SIGNS OF USE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCE¿S WERE NOTED. A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS AGAINST THIS LOT. APPROPRIATE DOCUMENTATION WAS REVIEWED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, PACKAGING MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE AS THE RECEIVED CONDITION OF THE PRODUCT IS UNKNOWN AND THE COMPLAINT CANNOT BE VERIFIED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: DATE OF THIS REPORT. DEVICE EXPIRATION. UDI IS N/A. DATE RECEIVED BY MANUFACTURER. CHECKED "FOLLOW-UP". CHECKED FOLLOW-UP TYPE. CHANGED "NO" TO "YES". DATE OF MANUFACTURE. ENTERED EVALUATION CODES. ADDED MANUFACTURER NARRATIVE.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). DATE OF BIRTH UNKNOWN / NOT PROVIDED, WEIGHT UNKNOWN / NOT PROVIDED, DATE OF EVENT UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBERS: K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRANSFER MOUNT WAS FOUND MISSING UPON OPENING OF THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1056260 IMPL SWISSPLUS OCTAGON 4. 1MM 12MM DENTAL IMPLANT DZE ZIMMER DENTAL 60721310

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR