BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    MDR report key: 8670636 · Received June 5, 2019

    Report

    Report Number
    0002023141-2019-00235
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Report Date
    August 29, 2019
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM (TSVB11) WAS RETURNED FOR INVESTIGATION WITH AN ATTACHED MOUNT (IMAGE 1-3). VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED MINIMAL WEAR AND DEBRIS ABOUT THE IMPLANT THREADS AND COLLAR. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCTS AND IT WAS DETERMINED THAT THE MOUNT SCREW AND HEX COULD BE EASILY REMOVED USING TSVKIT HAND TOOLS. NO FURTHER SIGNS OF DRIVE FEATURE DAMAGE OR DEBRIS WERE NOTED FOLLOWING MOUNT REMOVAL. THE REPORTED PRODUCT WAS TO BE PLACED ON AN UNKNOWN TOOTH SITE, BUT WAS REMOVED IMMEDIATELY FOLLOWING THE ALLEGED EVENT. THE CUSTOMER HAS NOT PROVIDED ADDITIONAL PICTURES OR X-RAY IMAGES OF THE PRODUCT. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1221638. 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 WAS PERFORMED FOR THE REPORTED LOT NUMBER (1221638) FOR SIMILAR CAUSE AND NO OTHER COMPLAINT WAS IDENTIFIED. JUNE POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO NEGATIVE TRENDS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (STUCK MOUNT) OR PRODUCT (TSVB11). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED. A DEFINITIVE CAUSE COULD NOT BE IDENTIFIED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: D4: UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4).

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). PATIENT WEIGHT: NOT PROVIDED. EVENT DATE: NOT PROVIDED. INITIAL REPORTER EMAIL ADDRESS, FAX NUMBER: NOT PROVIDED. PMA/510(K) NUMBER: K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ABUTMENT/ MOUNT COULD NOT DISENGAGE FROM IMPLANT (TSVB11). IMPLANT WAS REMOVED AND ANOTHER ONE WAS PLACED DURING THE SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462968 IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL 1221638

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR