BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 8.5MM

    MDR report key: 9647951 · Received January 30, 2020

    Report

    Report Number
    0001038806-2020-00217
    Event Type
    Malfunction
    Date Received
    January 30, 2020
    Date of Event
    January 7, 2020
    Report Date
    April 16, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K122300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE T3 NON-PLATFORM SWITCHED IMPLANT (BOST485) WAS RETURNED FOR INVESTIGATION. HOWEVER, THE CERTAIN® STRAIGHT HEALING ABUTMENT (ISHA43) WAS REPORTED BUT NOT RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED IMPLANT IDENTIFIED THAT THE DEVICE WAS IN GOOD CONDITION. FUNCTIONAL TESTING WAS PERFORMED USING AN IN-HOUSE DRIVER. THE DRIVER WAS ABLE TO ENGAGE AND DISENGAGE WITH THE IMPLANT SUCCESSFULLY. ADDITIONALLY, MEASUREMENTS WERE TAKEN USING A CALIPER (CAL3845, SEP 25, 2020). THROUGH DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS (DWG NO. 1040023 REV C), THE RETURNED IMPLANT WAS DETERMINED AS BOST485 INSTEAD OF THE REPORTED ONE (BOST410). LOT NUMBER WAS UPDATED TO UNKNOWN. PRE-EXISTING CONDITIONS, X-RAY IMAGE AND IMPLANTATION PERIOD ARE IRRELEVANT TO THIS INVESTIGATION. DOCTOR WAS ATTEMPTING TO PLACE DEVICES ON TOOTH #(B)(6) (UNIVERSAL) WHEN THE INCIDENT OCCURRED. PICTURES WERE NOT PROVIDED. DHR REVIEW COULD NOT BE PERFORMED SINCE THE LOT NUMBER WAS UNKNOWN. A YEAR-LONG COMPLAINT HISTORY REVIEW BY ITEM NUMBER (BOST485) WAS PERFORMED FOR SIMILAR EVENTS AND NO COMPLAINT ABOUT NONCONFORMING PRODUCTS WAS IDENTIFIED. FEBRUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICES. THEREFORE, BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TESTING, IMPLANT-RELATED MALFUNCTION DID NOT OCCUR AND ABUTMENT-RELATED MALFUNCTION COULD NOT BE VERIFIED AS IT WAS NOT RETURNED. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED. HOWEVER, THE PROBABLE CAUSES MAY BE RELATED TO A CLINICIAN CROSS-THREADS HEALING ABUTMENT OR CLINICIAN OVER-TORQUES HEALING ABUTMENT DURING PLACEMENT OF THE DEVICE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE DEVICE INVESTIGATION REPORTED IMPLANT AS BOST485. LOT NUMBER WAS UPDATED TO UNKNOWN.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). AGE: NOT PROVIDED. PATIENT WEIGHT: NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER IMPLANT PLACEMENT, DOCTOR WAS UNABLE TO SEAT THE HEALING ABUTMENT INTO THE IMPLANT (BOST410) AND THEREFORE, HE REMOVED BOTH THE IMPLANT AND THE HEALING ABUTMENT. DOCTOR PLACED A NEW IMPLANT WITH A COVER SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113194 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 4 X 8.5MM DENTAL IMPLANT DZE BIOMET 3I 2019020435

    Patients

    Seq Age Sex Outcome Treatment
    1