BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG

    MDR report key: 11864596 · Received May 21, 2021

    Report

    Report Number
    0001038806-2021-00887
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    October 26, 2020
    Report Date
    October 15, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    NDP
    UDI-DI
    00844868038870
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE 3I T3® TAPERED IMPLANT 5/4 X 8.5MM (BOPT5485) AND ONE INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP ¿ LONG (IIPDTUL) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED THAT THEY WERE ENGAGED INTO EACH OTHER. FUNCTIONAL TESTING WAS PERFORMED AND THE DEVICES WERE DETERMINED TO BE STUCK TO EACH OTHER. PRE-EXISTING PATIENT CONDITIONS, TOOTH LOCATION AND X-RAY IMAGES ARE IRRELEVANT TO THIS INVESTIGATION. PICTURES WERE NOT PROVIDED AND NO OTHER INFORMATION WAS PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBERS (1232169 & 2019020445). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURES. NO DEVIATIONS OR NON-CONFORMANCES, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WERE NOTED AS PART OF THE DHR. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS (1232169 & 2019020445) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION AND FUNCTIONAL TESTING, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP." H3: CHANGED "NO" TO "YES."

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. PMA/510(K) NUMBER UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BRAND NEW HEX DRIVER GOT STUCK DURING IMPLANT PLACEMENT, NEW IMPLANT PLACED RIGHT AWAY WITH SPARE IMPLANT AND DRIVER. TOOTH LOCATION # 14.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757901 INTERNAL CONNECTION UNIVERSAL PLACEMENT DRIVER TIP - LONG DRIVER NDP BIOMET 3I IIPDTUL 1232169 00844868038870

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention