BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE® CERTAIN® 2 IMPLANT 3.25 X 11.5MM

    MDR report key: 9131126 · Received September 27, 2019

    Report

    Report Number
    0001038806-2019-01132
    Event Type
    Injury
    Date Received
    September 27, 2019
    Date of Event
    April 25, 2019
    Report Date
    November 27, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K100724
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE OSSEOTITE® CERTAIN® 2 IMPLANT 3.25 X 11.5MM (XIFOSM311) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE, DRIED BLOOD AND BONE AROUND THE IMPLANT AND DAMAGED THREADS FROM REMOVAL. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENTS COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENTS. THE REPORTED DEVICE WAS MEASURED WITH CALIPERS (CAL1334 CAL DUE: SEP 25, 2020) AND WAS VERIFIED TO MATCH SPECIFICATIONS PER DWG NO 834039 REV B. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER, THE PATIENT HAD UNKNOWN BONE DENSITY. THE REPORTED DEVICE WAS LOCATED ON AN UNKNOWN TOOTH AND WAS USED FOR APPROXIMATELY 9 MONTHS. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. THE CUSTOMER REPORTED THE PATIENT HAD INFLAMMATION WHICH WILL NOT BE INVESTIGATED AS IT IS A SYMPTOM OF THE PERI-IMPLANTITIS EVENT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (2013120760). 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 EVENTS WERE NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. STERILIZATION RECORD (OP210) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (2013120760) FOR SIMILAR EVENTS AND NO OTHER RELEVANT COMPLAINT WAS IDENTIFIED. SEPTEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS (INFECTION & BONE LOSS) OR DEVICE (XIFOSM311). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENTS (INFECTION & BONE LOSS) WERE NON-VERIFIABLE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS WITH INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923804 OSSEOTITE® CERTAIN® 2 IMPLANT 3.25 X 11.5MM DENTAL IMPLANT DZE BIOMET 3I 2013120760

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention