BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SP 4.8MM 8MM OCTAGON

    MDR report key: 8701280 · Received June 14, 2019

    Report

    Report Number
    0002023141-2019-00281
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    April 23, 2019
    Report Date
    September 30, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K082639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNIFICANT WEAR AND DEBRIS ABOUT THE THREADS WITH ADDITIONAL DEBRIS IN THE OCTAGONAL DRIVE FEATURE. THE PRODUCT MATCHED PRINT SPECIFICATIONS WHERE MEASURED AGAINST DRAWING PD-SPWB8 REV L (DIGITAL CALIPER; CAL 3736; (B)(6) 2019). NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED PRODUCT WAS LOCATED ON TOOTH # 36 (FDI) AND USED FOR APPROXIMATELY 4 YEARS. DOCUMENT TYPE(S) REVIEWED: ¿INSTRUCTIONS FOR USE FOR SWISSPLUS® AND TAPERED SWISSPLUS® IMPLANTS¿ 9967 REV 0-09/14; WARNINGS + PRECAUTIONS; PAGE 2 DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 62899069. 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. STERILIZATION RECORD (ST2658) 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 (62899069) 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.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). DATE OF BIRTH UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBERS: K011245, K002188.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS WITH DEHISCENCE AND INFLAMMATION. TOOTH LOCATION 36.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494722 IMPL TAPERED SP 4.8MM 8MM OCTAGON IMPLANT DZE ZIMMER DENTAL 62899069

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR