BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,13,MTX,MG

    MDR report key: 12011259 · Received June 16, 2021

    Report

    Report Number
    0002023141-2021-01551
    Event Type
    Injury
    Date Received
    June 16, 2021
    Date of Event
    March 3, 2021
    Report Date
    October 8, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019942
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H6: INVESTIGATION TYPE CODES WERE ADDED: 3331, 4109, 4110 AND 4111. H6: INVESTIGATION FINDINGS CODE WAS ADDED: 213. H6: INVESTIGATION CONCLUSIONS CODES WERE ADDED: 67. H10: NARRATIVE/DATA WAS UPDATED. A IMP,TSV,3.7,13,MTX,MG (TSVTB13) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS DUE TO USAGE, HOWEVER NO DAMAGE IDENTIFIED. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. THE RETURNED DEVICE WAS MEASURED WITH A CALIPER AND VERIFIED TO MATCH DHR DRAWING. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE REPORTED DEVICE WAS LOCATED ON TOOTH #8 AND WAS USED FOR APPROXIMATELY A MONTH. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1240925). 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 (OP160) 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 (1240925) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. AUGUST POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS NON-VERIFIABLE.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. LAST/GIVEN NAME UNKNOWN / NOT PROVIDED. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #8 WAS REMOVED DUE TO EXTREME PAIN AND WAS LATER DIAGNOSED WITH PERI-IMPLANTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908020 IMP,TSV,3.7,13,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB13 1240925 00889024019942

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention