BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 3.75 MM 1 0 MM

    MDR report key: 16077724 · Received December 30, 2022

    Report

    Report Number
    0002023141-2022-03271
    Event Type
    Malfunction
    Date Received
    December 30, 2022
    Date of Event
    November 15, 2022
    Report Date
    May 2, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    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

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PMA/510(K): K943604.

    Additional Manufacturer Narrative · 0

    ONE (1) IMPL TWIST MP-1 3.75 MM 1 0 MM (1989-LZ) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT; VERIFIED THE MOUNT ENGAGED AND DISENGAGED FROM THE IMPLANT AS INTENDED. A PRE-EXISTING CONDITION NOTED ON THE PER WAS MODERATE BONE DENSITY (TYPE II). THE REPORTED DEVICE WAS LOCATED ON TOOTH # 12 (UNIVERSAL) AND WAS USED, PLACED AND REMOVED ON THE SAME DAY. THE CUSTOMER DID NOT PROVIDE ANY PICTURES OR X-RAYS. APPROPRIATE DOCUMENTATION WAS REVIEWED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (2021041010) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. FEBRUARY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT. NO ACTIONABLE ITEMS HAVE BEEN TRIGGERED THAT WILL AFFECT COMPLAINT HANDLING ON OUR END FOR THIS MONTH. BASED ON THE AVAILABLE INFORMATION, AND FUNCTIONAL TESTING DEVICE MALFUNCTION DID NOT OCCUR, AND THE REPORTED EVENT WAS UNCONFIRMED. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP". H3: CHANGED "NO" TO "YES".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT BODY CANNOT BE REMOVED FROM THE FIXTURE MOUNT. THE IMPLANT WAS REMOVED, AND ANOTHER IMPLANT WAS PLACED.

    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
    2825880 IMPL TWIST MP-1 3.75 MM 1 0 MM DENTAL IMPLANT DZE ZIMMER DENTAL 1989 2021041010

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female