BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 11.5MM

    MDR report key: 8775176 · Received July 10, 2019

    Report

    Report Number
    0001038806-2019-00659
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    August 17, 2018
    Report Date
    September 30, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ONE 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 11.5MM (BOST3211) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WEAR AND DEBRIS ABOUT THE IMPLANT THREADS. THE PRODUCT MATCHED PRINT SPECIFICATIONS WHERE MEASURED AGAINST DRAWING 1040021 REV C. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE CUSTOMER HAS RETURNED AN X-RAY OF THE SURGICAL SITE, AND SME REVIEW NOTED THAT THE APICAL PORTIONS OF TOOTH SITES 12 AND 13 WERE TOO CLOSE TO PROPERLY INTEGRATE. APPROPRIATE DOCUMENTATION WAS REVIEWED AND THE FOLLOWING INFORMATION WAS IDENTIFIED: DOCUMENTS REVIEWED: ZBINSTSM REV A 06/19; IMPLANT DEPTH/DIRECTION INDICATOR. 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. IT WAS REPORTED THAT THE IMPLANT (BOST3211) WAS REMOVED BECAUSE IT WAS IMPLANTED AT A SEVERELY BAD ANGLE. BASED ON X-RAY IMAGED, THE COMPLAINT WAS CONFIRMED. A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D4: EXPIRATION DATE. G4: DATE RECEIVED BY MANUFACTURER. G7: TYPE OF REPORT, FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES.' H4: DEVICE MANUFACTURE DATE. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT (BOST3211) WAS REMOVED BECAUSE IT WAS IMPLANTED AT A SEVERELY BAD ANGLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568411 3I T3® NON-PLATFORM SWITCHED TAPERED IMPLANT 3.25 X 11.5MM IMPLANT DZE BIOMET 3I 2018021824

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention