BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 3.75 MM 8 MM

    MDR report key: 12271837 · Received August 3, 2021

    Report

    Report Number
    0002023141-2021-02013
    Event Type
    Malfunction
    Date Received
    August 3, 2021
    Date of Event
    June 30, 2021
    Report Date
    December 27, 2021
    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 TYPE III (LOW) BONE DENSITY. THE IMPLANT HAD BEEN PLACED ON TOOTH #12 (UNIVERSAL) AND WAS REMOVED THE SAME DAY. THE REPORTED EVENT COULD NOT BE RECREATED WHEN 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 2020060164. 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 (2020060164) WAS PERFORMED FOR SIMILAR EVENTS AND 1 OTHER SIMILAR COMPLAINT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS NOT OCCURRED AND THE REPORTED EVENT WAS UNCONFIRMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED:

    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). PATIENT WEIGHT UNKNOWN / NOT PROVIDED. PMA/510K: K943604.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR PLACED AN IMPLANT IN A PATIENT'S MOUTH AND ATTEMPTED TO REMOVE THE FIXTURE MOUNT, BUT IT WAS TOO HARD TO REMOVE. THE DOCTOR REMOVED THE IMPLANT AND INSTALLED ANOTHER PRODUCT THAT THE CLINIC HAD IN STOCK.TOOTH SITE # 12.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1163725 IMPL TWIST MP-1 3.75 MM 8 MM DENTAL IMPLANT DZE ZIMMER DENTAL 1988 2020060164 00889024013117

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female