BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 5.0 MM 10 MM

    MDR report key: 9961877 · Received April 15, 2020

    Report

    Report Number
    0002023141-2020-00767
    Event Type
    Malfunction
    Date Received
    April 15, 2020
    Date of Event
    February 29, 2020
    Report Date
    June 18, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024013179
    PMA / PMN Number
    K013494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANT WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE RETURNED DEVICE IDENTIFIED THE IMPLANT HAD DRIED BLOOD AND SIGNS OF USE AND FAILED FUNCTIONAL TESTING AS IT TOOK EXCESSIVE FORCE TO REMOVE THE MOUNTS. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER AND THE PATIENT HAD UNKNOWN BONE DENSITY. THE REPORTED DEVICE WAS INTENDED FOR USE ON TOOTH #19 (UNIVERSAL) AND WERE USED FOR A SINGLE DAY/PROCEDURE. THE CUSTOMER DID NOT PROVIDE PICTURES OR ADDITIONAL EVIDENCE. APPROPRIATE DOCUMENTATION WAS REVIEWED. A DHR REVIEWS WERE COMPLETED FOR THE SUBJECT LOT NUMBER. 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 DHRS. LOTS WERE INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. A COMPLAINT HISTORY REVIEWS WERE PERFORMED FOR THE REPORTED LOT NUMBER FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED FOR THE IMPLANT AS THE DEVICE FAILED FUNCTIONAL TESTING AS IT TOOK EXCESSIVE FORCE TO REMOVE THE MOUNT. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: CHANGED "NO" TO "YES."

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PATIENT SEX UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. K962106.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTS BODY CANNOT BE REMOVED FROM THE DELIVERY MOUNTS. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH LOCATION #19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425539 IMPL TWIST MP-1 5.0 MM 10 MM DENTAL IMPLANT DZE ZIMMER DENTAL 1994 63757004 00889024013179

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention