BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 10MM

    MDR report key: 9316614 · Received November 13, 2019

    Report

    Report Number
    0001038806-2019-01362
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    May 22, 2019
    Report Date
    January 10, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 10MM (INT510) WAS RETURNED FOR INVESTIGATION WITH AN ATTACHED CROWN. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WEAR AND DEBRIS ABOUT THE IMPLANT THREADS. THE PRODUCT MATCHED PRINT SPECIFICATIONS WHERE MEASURED AGAINST DRAWING 223244 REV V. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 29 AND USED FOR APPROXIMATELY 10 YEARS. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 216322. 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 EVENTS WAS NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. STERILIZATION RECORD WAS NOT REVIEWED, AS THE PRODUCT WAS PLACED FOLLOWING STERILE PACKAGING EXPIRATION DATE, THUS INVALIDATING STERILIZATION ASSURANCE. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (216322) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS (INFECTION & BONE LOSS) OR PRODUCT (INT510). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED AND THE REPORTED EVENTS WERE NON-VERIFIABLE. INFECTION AND BONE LOSS ARE LISTED AS A HARM OR POTENTIAL EFFECT OF IMPLANT FAILURE. 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. 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 IMPLANT (INT510) WAS REMOVED DUE TO PERIIMPLANTITIS AT TOOTH LOCATION 29.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109502 OSSEOTITE® TAPERED CERTAIN® IMPLANT 5 X 10MM DENTAL IMPLANT DZE BIOMET 3I 216322

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention