BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE® IMPLANT 3.75 X 13MM

    MDR report key: 12369222 · Received August 26, 2021

    Report

    Report Number
    0001038806-2021-01602
    Event Type
    Injury
    Date Received
    August 26, 2021
    Date of Event
    August 27, 2020
    Report Date
    January 26, 2022
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTION HAS BEEN UPDATED: H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. TWO OSSEOTITE® IMPLANT 3.75 X 13MM (OSS313) WERE RETURNED FOR INVESTIGATION . VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED BOTH IMPLANTS FRACTURED AROUND THE COLLARS REGION. ADDITIONALLY, A SCREW FRAGMENT WAS IDENTIFIED IN ONE OF THE IMPLANTS' DRIVE FEATURE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS MODERATE BONE DENSITY (TYPE II). THE REPORTED DEVICES WERE LOCATED ON TOOTH SITES 12, AND 21 (FDI) AND WERE USED FOR APPROXIMATELY 11 YEARS, AND 8 MONTHS. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: BIOMET 3I DENTAL IMPLANT IFU (P-IIS086GI) REV. H - JULY 2021 INFORMATION IDENTIFIED: WARNINGS PRECAUTIONS POTENTIAL ADVERSE EVENTS. DOCUMENTS REVIEWED: BIOMET 3I RESTORATIVE PRODUCTS IFU (P-IIS086GR) REV. F ¿ OCTOBER 2019 INFORMATION IDENTIFIED: WARNINGS PRECAUTIONS POTENTIAL ADVERSE EVENTS. DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (831319). IT WAS CONFIRMED THAT ALL OPERATIONS AND INSPECTIONS WERE EXECUTED AS PER APPLICABLE PROCEDURE. NO DEVIATIONS OR NON-CONFORMANCES, 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. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (831319) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: FRACTURE IMPLANT AND SCREW. POST MARKET TREND REVIEW: NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS OR PRODUCT. NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENTS WERE CONFIRMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. EXPIRATION DATE AND UDI UNKNOWN / NOT PROVIDED. DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    THE DOCTOR REPORTS THAT THE IMPLANTS WERE FRACTURED AND HE DOES NOT KNOW IF IT WAS DUE TO OVERLOAD SINCE HE DID NOT MAKE THE PROSTHESIS TO THE PATIENT. THE AFFECTED DENTAL POSITIONS ARE 12 AND 21.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267845 OSSEOTITE® IMPLANT 3.75 X 13MM DENTAL IMPLANT DZE BIOMET 3I 831319

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention