BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 3.75 MM 8 MM

    MDR report key: 12509497 · Received September 21, 2021

    Report

    Report Number
    0002023141-2021-02633
    Event Type
    Malfunction
    Date Received
    September 21, 2021
    Date of Event
    July 16, 2021
    Report Date
    February 22, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024013117
    PMA / PMN Number
    K013494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TWIST MP-1 3.75 MM 8 MM (1988) AND MOUNT WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE. PRE-EXISTING CONDITION AS NOTED ON THE PER WAS UNKNOWN. THE IMPLANT HAD BEEN PLACED ON TOOTH #30 (UNIVERSAL) AND WAS REMOVED THE SAME DAY. THE RETURNED PRODUCT WAS FUNCTIONALLY TESTED. THE MOUNT WAS ABLE TO DISENGAGE WITH LITTLE EFFORT USING NORMAL HAND TOOLS. X-RAY OR PICTURE IMAGE WAS NOT PROVIDED. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 2021010660. 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 BY LOT NUMBER (2021010660) WAS PERFORMED FOR SIMILAR EVENT AND NO OTHER SIMILAR COMPLAINT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED AND THE REPORTED EVENT WAS UNCONFIRMED.

    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). PMA/510K: K943604.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED. TOOTH SITE # 30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405360 IMPL TWIST MP-1 3.75 MM 8 MM DENTAL IMPLANT DZE ZIMMER DENTAL 1988 2021010660 00889024013117

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose