BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,11.5,MTX,MG

    MDR report key: 11358404 · Received February 22, 2021

    Report

    Report Number
    0002023141-2021-00442
    Event Type
    Malfunction
    Date Received
    February 22, 2021
    Date of Event
    January 19, 2021
    Report Date
    June 10, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020009
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TAPERED SCREW VENT (TSVTWB11) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS INDICATED SIGNIFICANT SIGNS OF USE. IMPLANT INTERNAL DRIVE FEATURE IDENTIFIED DAMAGED AS WELL. BONE DEBRIS PRESENT ON THE EXTERNAL THREADS. FUNCTIONAL TESTING WAS PERFORMED FOR THE RETURNED PRODUCTS. PATIENT PRE-EXISTING CONDITION IS PATIENT HAVING HIGH (TYPE I) BONE DENSITY. TOOTH LOCATION IS #19 (UNIVERSAL). HOWEVER, IMPLANT PLACEMENT DATE WAS NOT PROVIDED BY CUSTOMER. DHR REVIEW: DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 1231162. 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 (TSVTWB11 AND HC443): COMPLAINT HISTORY REVIEW BY LOT NUMBER (1231162) WAS PERFORMED FOR SIMILAR EVENTS. POST MARKET TRENDING REVIEW: MONTHLY POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT (DOES NOT SEAT) OR PRODUCT (TSVTWB11). THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT'S WEIGHT NOT PROVIDED. DATE THE IMPLANT WAS PLACED NOT PROVIDED. ADDITIONAL 510(K) NUMBER IS K101880.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE FINAL ROTATION THE FINAL ABUTMENT COULD NOT BE SEATED. THE IMPLANT BECAME STRIPPED AND HAD TO BE REMOVED AND REPLACED WITH A NEW ONE AT THE SAME SITE. THE IMPLANT WAS WELL INTEGRATED AT THE TIME OF REMOVAL. PATIENT WILL RETURN FOR ANOTHER APPOINTMENT. LOT PROVIDED FOR ABUTMENT VIA EMAIL. TOOTH #19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258674 IMP,TSV,4.7,11.5,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWB11 1231162 00889024020009

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR