BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 11.5MM

    MDR report key: 9151954 · Received October 3, 2019

    Report

    Report Number
    0001038806-2019-01144
    Event Type
    Injury
    Date Received
    October 3, 2019
    Date of Event
    May 24, 2019
    Report Date
    December 11, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 11.5MM (IFNT411) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED MINOR WEAR ABOUT THE IMPLANT THREADS AND INTERNAL DRIVE FEATURE. THE RETURNED PRODUCT MATCHED PRINT SPECIFICATIONS WHERE MEASURED AGAINST DRAWING 223410 REV M (DIGITAL CALIPER; CAL1334 CAL DUE: SEP 25, 2020). NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 9 AND REMOVED THE SAME DAY. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2017050258. IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCE, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (2017050258) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. OCTOBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (INCORRECT IMPLANT FIT) OR PRODUCT (IFNT411). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED AND THE REPORTED EVENT WAS NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. D4: UNIQUE IDENTIFIER (UDI) NUMBER. D4: EXPIRATION DATE. G4: DATE RECEIVED BY MANUFACTURER. G7: CHECKED "FOLLOW-UP." H2: CHECKED FOLLOW-UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H4: MANUFACTURER DATE. H6: ENTERED EVALUATION CODES. H10: 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 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT PLACEMENT DOCTOR DISCOVERED THAT THE IMPLANT (IFNT411) DID NOT FIT CORRECTLY. IMPLANT WAS REMOVED AND SITE WAS BONE GRAFTED. TOOTH LOCATION 9.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945434 FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 11.5MM DENTAL IMPLANT DZE BIOMET 3I 2017050258

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention