BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE® IMPLANT 3.75 X 13MM

    MDR report key: 9469032 · Received December 13, 2019

    Report

    Report Number
    0001038806-2019-01618
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    October 7, 2019
    Report Date
    February 28, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ONE OSSEOTITE® IMPLANT 3.75 X 13MM (OSS313) WAS RETURNED FOR INVESTIGATION (IMAGE 1). VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED A COMPLETE FRACTURE ACROSS THE THREADS. THERE WAS PRESENCE OF DRIED BLOOD AND BONE AROUND THE EXTERNAL THREADS. ALSO, ACCORDING TO THE IFU, PATIENT FACTORS LIKE PRESENCE OF OCCLUSAL ABNORMALITIES OR PARAFUNCTIONAL HABITS (E.G. SEVERE BRUXISM, CLENCHING, OVERLOADING OR GNAWING) MAY CAUSE SCREW LOOSENING, RESTORATION FRACTURE, AND/OR IMPLANT FAILURE. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (163679). 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 (163679) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. DECEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (IMPLANT FRACTURE) OR DEVICE (OSS313) THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED. NO FURTHER INVESTIGATION OR IMMEDIATE CAPA/HHE/D ESCALATION IS REQUIRED, AS THE COMPLAINT INVESTIGATION DID NOT CONFIRM THE PRODUCT WAS NONCONFORMING AT THE TIME OF DISTRIBUTION, AND NO NEW FAILURE MODE, HARM, OR HAZARDOUS SITUATION WAS IDENTIFIED THROUGH THE INVESTIGATION PERFORMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT; D4: EXPIRATION DATE AND UDI; 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

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO FRACTURE. TOOTH LOCATION 12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263573 OSSEOTITE® IMPLANT 3.75 X 13MM DENTAL IMPLANT DZE BIOMET 3I 163679

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention