BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,MCOL MG,4.7MM,11.5MML

    MDR report key: 10499173 · Received September 7, 2020

    Report

    Report Number
    0002023141-2020-01375
    Event Type
    Malfunction
    Date Received
    September 7, 2020
    Date of Event
    July 29, 2020
    Report Date
    December 29, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019782
    PMA / PMN Number
    K111889
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE TAPERED SCREW-VENT IMPLANT (TSVMWB11) 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 19 BUT COULD NOT FINISH PROCEDURE SINCE THE MOUNT WAS UNABLE TO DISENGAGE AND PROCEDURE WAS COMPLETED USING ANOTHER DEVICE.X-RAY OR PICTURE IMAGE WAS NOT PROVIDED. INSTRUCTIONS FOR USE - TAPERED SCREW-VENT AND TRABECULAR METAL IMPLANTS, IFU4869 REV 9-10/19. INFORMATION IDENTIFIED: WARNINGS, PRECAUTIONS AND BREAKAGE (PAGES 1 AND 2). PER THE APPLICABLE IFU, IT IS STATED THAT IMPROPER TECHNIQUE CAN CAUSE DEVICE FAILURE. DHR REVIEW FOR THE LOT NUMBER (1231839) 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 BY LOT NUMBER (1231839) WAS PERFORMED FOR SIMILAR EVENTS AND NO COMPLAINT ABOUT NONCONFORMING PRODUCTS WAS IDENTIFIED. OCTOBER 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

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). AGE AND DATE OF BIRTH UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION PMA/510(K) NUMBER K101880.

    Description of Event or Problem · 1

    DOCTOR REPORTED THAT MOUNT COULD NOT DISENGAGE FROM IMPLANT AT TOOTH SITE 36 AFTER IMPLANT PLACEMENT. THE PROCEDURE HAS BEEN COMPLETED WITH ANOTHER DEVICE. THERE WAS A DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    963048 IMP,TSV,MCOL MG,4.7MM,11.5MML DENTAL IMPLANT DZE ZIMMER DENTAL TSVMWB11 1231839 00889024019782

    Patients

    Seq Age Sex Outcome Treatment
    1