BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE® CERTAIN® IMPLANT 5 X 10MM

    MDR report key: 8739561 · Received June 27, 2019

    Report

    Report Number
    0001038806-2019-00590
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    May 23, 2019
    Report Date
    September 30, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WEAR AND A LARGE AMOUNT OF BONE DEBRIS ABOUT THE IMPLANT THREADS. THE INTERNAL DRIVE FEATURE IS HEAVILY WORN FROM USE. THE PRODUCT MATCHED PRINT SPECIFICATIONS WHERE MEASURED AGAINST DRAWING 223029 REV Z (DIGITAL CALIPER; CAL 3736; (B)(6)2019). NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 30 (UNIVERSAL) AND USED FOR APPROXIMATELY 11.5 YEARS. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTSM REV D 08/18; PAGE 2; POTENTIAL ADVERSE EVENTS AND PRECAUTIONS DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 626729. 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 COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (626729) FOR SIMILAR CAUSE AND NO OTHER COMPLAINT WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE DUE TO THE NATURE OF THE REPORTED EVENT. NO 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: DATE OF THIS REPORT, EXPIRATION DATE, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT, FOLLOW-UP NUMBER, FOLLOW UP TYPE, DEVICE EVALUATED BY MANUFACTURER: CHANGE 'NO' TO 'YES', DEVICE MANUFACTURE DATE, EVALUATION CODES, ADDITIONAL NARRATIVE.

    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 IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PAIN AND THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533545 OSSEOTITE® CERTAIN® IMPLANT 5 X 10MM DENTAL IMPLANT DZE BIOMET 3I 626729

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention