BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,10,MTX,MG

    MDR report key: 14372499 · Received May 12, 2022

    Report

    Report Number
    0002023141-2022-01165
    Event Type
    Injury
    Date Received
    May 12, 2022
    Report Date
    October 18, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019928
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). EVENT DATE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ONE (1) IMP,TSV,3.7,10,MTX,MG (TSVTB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT WITHIN SPECIFICATIONS - MEASURED WITH CAL1322 (DUE: SEP 2, 2022). NO MALFUNCTION IDENTIFIED. 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 MODERATE BONE DENSITY (TYPE II), DIABETES, HYPERTENSION. THE REPORTED DEVICE WAS LOCATED ON TOOTH # 20 (UNIVERSAL) AND WAS USED FOR APPROXIMATELY 7 DAYS. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE - TAPERED SCREW-VENT AND TRABECULAR METAL IMPLANTS, IFU4869 REV 9-10/19. INFORMATION IDENTIFIED: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND ADVERSE EFFECTS. PER THE APPLICABLE IFU, LOCAL AND GENERALIZED ALLERGIC REACTIONS ARE LISTED AS ADVERSE EFFECTS. ALSO, IT IS STATED THAT SOME ADVERSE EFFECTS MAY OCCUR AS A RESULT OF IATROGENIC FACTORS AND HOST RESPONSES. DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1251903). 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, WERE NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. STERILIZATION RECORD REVIEW: STERILIZATION RECORD (OP#150) 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 (1251903) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: ALLERGIC REACTION. POST MARKET TRENDING REVIEW: AUGUST POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (ALLERGIC REACTION) OR PRODUCT (TSVTB10). 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. THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF THE EVENT WERE NON-VERIFIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT BELIEVED SHE WAS HAVING ALLERGIC REACTION AND DEMANDED THE IMPLANT BE REMOVED. TOOTH 20.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082842 IMP,TSV,3.7,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB10 1251903 00889024019928

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention