BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 11.5MM

    MDR report key: 8767249 · Received July 8, 2019

    Report

    Report Number
    0001038806-2019-00651
    Event Type
    Injury
    Date Received
    July 8, 2019
    Report Date
    October 17, 2019
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WEAR AND DEBRIS ABOUT THE IMPLANT THREADS AND COLLAR. THE PRODUCT MATCHED PRINT SPECIFICATIONS WHERE MEASURED AGAINST DRAWING 223410 REV M (DIGITAL CALIPER; CAL 3736; OCT 23, 2019). NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 4 (UNIVERSAL) AND USED FOR APPROXIMATELY 7.5 YEARS PRIOR TO REMOVAL. DOCUMENTS REVIEWED: ZBINSTSM REV A 06/19; POTENTIAL ADVERSE EVENTS AND PRECAUTIONS DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2010121282. 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 (2010121282) 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. 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: 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

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PAIN. TOOTH LOCATION 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563742 FULL OSSEOTITE® TAPERED CERTAIN® IMPLANT 4 X 11.5MM DENTAL IMPLANT DZE BIOMET 3I 2010121282

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention