BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3® WITH DCD® TAPERED IMPLANT 6/5 X 15MM

    MDR report key: 8775832 · Received July 10, 2019

    Report

    Report Number
    0001038806-2019-00660
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    August 23, 2018
    Report Date
    October 23, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE 3I T3® WITH DCD® TAPERED IMPLANT 6/5 X 15MM (BNPT6515) WAS RETURNED FOR INVESTIGATION WITH A BUNDLED COVER SCREW THREADED INTO THE IMPLANT. VISUAL INSPECTION OF THE RETURNED PRODUCTS IDENTIFIED MAJOR WEAR AND SIGNS OF USE, DRIED BONE AROUND THE IMPLANT DAMAGED THREADS FROM REMOVAL. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENTS COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICES & EVENTS. THE REPORTED DEVICES WERE MEASURED WERE VERIFIED TO MATCH SPECIFICATIONS PER DWG. NO. 1040012 REV C. PRE-EXISTING CONDITIONS NOTED ON THE PER WERE ALLOGRAFT, XENOGRAFT & PLATELET RICH PLASMA (PRP) GRAFTED SITE AND HIGH (TYPE I) BONE DENSITY. THE REPORTED DEVICE WAS USED FOR APPROXIMATELY 3 YEARS 3 MONTHS. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED OF THE MEDICAL EVENT. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: DOCUMENTS REVIEWED: BIOMET 3I DENTAL IMPLANT IFU (P-IIS086GI REV F 11/2015) & BIOMET 3I SURGICAL MANUAL FOR TAPERED AND PARALLEL WALLED IMPLANTS (INSTSM REV H 08/18) INFORMATION IDENTIFIED: WARNINGS PRECAUTIONS STERILITY POTENTIAL ADVERSE EVENTS. A DEVICE HISTORY REVIEW WAS PERFORMED AND NO RELATED NONCONFORMANCES WERE NOTED. ALSO, A COMPLAINT HISTORY SEARCH WAS PERFORMED USING OUR COMPLAINT HANDLING SYSTEM AND THERE WERE NO ADDITIONAL RELATED COMPLAINTS FOR THIS PRODUCT LOT. COMPLAINANT REPORTED THAT THE IMPLANT DEVELOPED SEVERE BONE LOSS AND GINGIVAL RECESSION WITH 2/3 - 3/4 OF BUCCAL THREADS EXPOSED. THE IMPLANT WERE REMOVED AND SITES BONE-GRAFTED FOR FUTURE IMPLANT REPLACEMENT. THE REPORTED COMPLAINT COULD NOT BE VERIFIED. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: DATE OF THIS REPORT. EXPIRATION DATE, UDI. DATE RECEIVED BY MANUFACTURER. TYPE OF REPORT, FOLLOW-UP NUMBER. FOLLOW UP TYPE. DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. DEVICE MANUFACTURE DATE. EVALUATION CODES. ADDITIONAL NARRATIVE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT SITE DEVELOPED INFECTION AND BONE LOSS. THE IMPLANT WAS REMOVED AND THE SITE GRAFTED FOR FUTURE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569825 3I T3® WITH DCD® TAPERED IMPLANT 6/5 X 15MM IMPLANT DZE BIOMET 3I 2015020532

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention