BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,11.5,MTX,MG

    MDR report key: 11334609 · Received February 16, 2021

    Report

    Report Number
    0002023141-2021-00406
    Event Type
    Injury
    Date Received
    February 16, 2021
    Date of Event
    January 8, 2021
    Report Date
    May 25, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019935
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION / RESULTS: ONE (1) IMP, TSV, 3.7, 11.5, MTX ,MG (TSVTB11) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT HAD NO SIGN OF FRACTURE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. A PRE-EXISTING CONDITION NOTED ON THE PER WAS UNKNOWN BONE DENSITY TYPE, PATIENT HAS DIABETES. THE REPORTED DEVICE WAS LOCATED ON AN UNKNOWN TOOTH SITE, AND WAS USED FOR APPROXIMATELY 7 MONTHS AND 19 DAYS. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. ALSO, ACCORDING TO THE IFU, PATIENT FACTORS LIKE PRESENCE OF OCCLUSAL ABNORMALITIES OR PARAFUNCTIONAL HABITS (E.G. SEVERE BRUXISM, CLENCHING, OVERLOADING OR GNAWING) MAY CAUSE SCREW LOOSENING, RESTORATION FRACTURE, AND/OR IMPLANT FAILURE. DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER: (1231832). 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: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER: (1231832) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: FEBRUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (FRACTURE) OR PRODUCT (TSVTB11). NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED. SECTIONS UPDATED: B4: DATE OF THIS REPORT. G3: DATE INVESTIGATION RESULTS WERE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT AND FOLLOW UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED. H6: ADVERSE EVENT PROBLEM CODES. H10: MANUFACTURER'S NARRATIVE.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT FRACTURED REQUIRING THE IMPLANT TO BE REMOVED. A NEW IMPLANT WAS PLACED AT THE SAME SITE ON (B)(6) 2021. NO TOOTH NUMBER WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232244 IMP,TSV,3.7,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB11 1231832 00889024019935

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention