BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.7,13,MTX,MG

    MDR report key: 12358662 · Received August 24, 2021

    Report

    Report Number
    0002023141-2021-02271
    Event Type
    Injury
    Date Received
    August 24, 2021
    Report Date
    January 26, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020016
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMP,TSV,4.7,13,MTX,MG (TSVTWB13) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED NO SIGNS OF APPARENT MALFUNCTION. BONE DEBRIS ON THE EXTERNAL THREADS. MEASUREMENT MATCHED PRINT CAL1831 (DUE: (B)(6) 2022). PRE-EXISTING PATIENT CONDITION NOTED ON THE PER WAS PATIENT HAVING TYPE III (LOW) BONE DENSITY. THE REPORTED DEVICE WAS BEING PLACED ON TOOTH # 4 (UNIVERSAL) WHEN THE INCIDENT OCCURRED AND THE IMPLANT HAD BEEN PLACED FOR ABOUT 3 WEEKS. THE REPORTED EVENT COULD NOT BE RECREATED DUE TO THE NATURE OF THE DENTAL DEVICE AND EVENT. X-RAY OR PICTURE IMAGE WAS NOT PROVIDED BY CUSTOMER. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE - TAPERED SCREW-VENT AND TRABECULAR METAL IMPLANTS, IFU4869 REV 9-10/19. 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 1241365. 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: STERILIZATION RECORD (OP160) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1241365) FOR SIMILAR EVENTS USING KEYWORD ALLERGIC REACTION, MEDICAL- BONE LOSS, MEDICAL: INFECTION AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: (B)(6) POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED DEVICES AND EVENTS. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENTS WERE NON-VERIFIABLE WITH THE INFORMATION AVAILABLE. SECTIONS UPDATED: B4: DATE OF THIS REPORT. D9: DEVICE AVAILABILITY AND PRODUCT RETURN DATE. G3: DATE INVESTIGATION RESULTS WERE RECEIVED. G6: TYPE OF REPORT AND FOLLOW UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. 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 (B)(4). PATIENT'S WEIGHT NOT PROVIDED. EVENT DATE NOT PROVIDED. ADDITIONAL 510(K) NUMBER IS K101880.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD CONTINUOUS PAIN AT SURGICAL SITE THROUGHOUT HEALING. PATIENT RETURNED TO POST OP APPOINTMENT WHERE BONE LOSS, INFECTION AND A LACK OF INTEGRATION WAS FOUND. DOCTOR BELIEVES PATIENT MAY HAVE HAD AN ALLERGIC REACTION WITH INFLAMMATION AND AN ABSCESS. IMPLANT WAS REMOVED AND SITE WAS GRAFTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1258664 IMP,TSV,4.7,13,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWB13 1241365 00889024020016

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention