BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TWIST MP-1 5.0 MM 10 MM

    MDR report key: 12872532 · Received November 24, 2021

    Report

    Report Number
    0002023141-2021-03391
    Event Type
    Malfunction
    Date Received
    November 24, 2021
    Date of Event
    August 25, 2021
    Report Date
    May 27, 2022
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN IMPL TWIST MP-1 5.0 MM 10 MM (1994) WAS RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS DUE TO USAGE AND A FRACTURE AT THE SPLINES OF A MOUNT. REMOVAL TOOL STUCK IN IMPLANT. PRE-EXISTING PATIENT FACTORS, X-RAY, TOOTH LOCATION ARE NOT RELEVANT TO THE REPORTED EVENT. THE LENGTH OF USAGE OF THE DEVICE IS SAME DAY. PICTURES OR X-RAY IMAGES WERE NOT PROVIDED. DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE FOR ZIMMER DENTAL SPLINE® TWIST¿ IMPLANTS¿ 8962 REV 3 - 09/19 INFORMATION IDENTIFIED: CONTRAINDICATIONS, WARNINGS DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (2019072563). 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: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (2019072563) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TREND REVIEW: MARCH POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR DEVICE. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL 510(K) NUMBER IS K962106.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE DOCTOR PLACED THE IMPLANT, THE SLOT PART OF THE FIXTURE MOUNT FRACTURED. THE DOCTOR STOPPED USING THE FIXTURE MOUNT AND USED A REMOVAL TOOL TO REMOVE THE IMPLANT AND THEN PLACED ANOTHER IMPLANT. TOOTH # 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770579 IMPL TWIST MP-1 5.0 MM 10 MM DENTAL IMPLANT AND MOUNT DZE ZIMMER DENTAL 1994 2019072563 00889024013179

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male