BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM

    MDR report key: 15292646 · Received August 25, 2022

    Report

    Report Number
    0002023141-2022-02193
    Event Type
    Malfunction
    Date Received
    August 25, 2022
    Date of Event
    August 10, 2022
    Report Date
    January 23, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020085
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). K011028, K013227.

    Additional Manufacturer Narrative · 0

    ONE (1) IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM ((B)(6)), ONE (1) HEAL COLLAR 4.5X5.5, 5MM (HC455) & ONE (1) UNKNOWN IMPRESSION COPING WERE NOT RETURNED FOR INVESTIGATION. VISUAL INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION HAS BEEN PERFORMED BASED ON THE AVAILABLE INFORMATION USING THE ITEM AND LOT NUMBER ALONG WITH THE APPLICABLE DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), AND RISK FILE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE & EVENT. NO PRE-EXISTING CONDITION NOTED, AND NO PER FORM WAS PROVIDED. BONE DENSITY TYPE IS UNKNOWN. THE REPORTED DEVICES WERE LOCATED ON AN UNKNOWN TOOTH SITE (UNIVERSAL) AND WERE USED FOR AN UNKNOWN AMOUNT OF TIME. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBERS (1231762, 2019051702). 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 NUMBERS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. DHR REVIEW AND COMPLAINT HISTORY REVIEW BY LOT NUMBER COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT (UNKNOWN IMPRESSION COPING) IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBERS (1231762, 2019051702) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENTS. NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED, AND THE REPORTED EVENTS WERE NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT G3: DATE RECEIVED BY MANUFACTURER G6: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H3: CHANGED "YES" TO "NO" H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE H3 OTHER TEXT : DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DOCTOR HAD TROUBLE REMOVING HEALING ABUTMENT AND COULD ONLY GET IMPRESSION COPING SCREW TO ENGAGE 3/4 OF THE WAY. IT WOULD TIGHTEN BUT NOT COMPLETELY RETAIN COPING. NEED RE-THREADING TOOL.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460553 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 8MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB8 1231762 00889024020085

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention