BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,4.7,8,MTX,MG

    MDR report key: 10657200 · Received October 9, 2020

    Report

    Report Number
    0002023141-2020-01633
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    August 25, 2020
    Report Date
    February 4, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020030
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TAPERED SCREW-VENT IMPLANT (TSVTWB8) AND MOUNT WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SOME SIGNS OF USAGE DUE TO STUCK MOUNT. FUNCTIONAL TESTING WAS PERFORMED. THE MOUNT WAS STUCK IN THE IMPLANT AND COULD NOT BE DISENGAGED. NO PRE-EXISTING CONDITION WAS NOTED ON THE PER. THE IMPLANT HAD BEEN PLACED ON TOOTH #3 BUT COULD NOT FINISH PROCEDURE SINCE THE MOUNT WAS UNABLE TO DISENGAGE AND PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. PER THE APPLICABLE IFU, IT IS STATED THAT IMPROPER TECHNIQUE CAN CAUSE DEVICE FAILURE. DHR REVIEW: DHR REVIEW FOR THE LOT NUMBER (1220986) HAD REVEALED NO DEVIATIONS NOR NON-CONFORMANCES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL PRODUCTS WERE CONFORMING AT THE TIME THEY LEFT ZIMMER BIOMET. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW BY LOT NUMBER (1220986) WAS PERFORMED FOR SIMILAR EVENTS AND NO COMPLAINT ABOUT NONCONFORMING PRODUCTS WAS IDENTIFIED. POST MARKET TRENDING REVIEW: NOVEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. 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

    (B)(4). PATIENT'S WEIGHT IS UNKNOWN. ADDITIONAL 510(K) NUMBER IS K101880.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FIXTURE MOUNT WOULD NOT RELEASE FROM THE IMPLANT BODY. THERE WAS A 10 MINUTE DELAY IN THE PROCEDURE. IMPLANT WAS REMOVED AND ANOTHER IMPLANT WAS PLACED THE SAME DAY. TOOTH #3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1118785 IMP,TSV,4.7,8,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTWB8 1220986 00889024020030

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR