BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP,TSV,3.7,8,MTX,MG

    MDR report key: 13647876 · Received March 2, 2022

    Report

    Report Number
    0002023141-2022-00538
    Event Type
    Malfunction
    Date Received
    March 2, 2022
    Date of Event
    October 28, 2021
    Report Date
    August 11, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019966
    PMA / PMN Number
    K101977
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. EXPIRATION DATE INFORMATION UNKNOWN / NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ONE (1) IMP,TSV,3.7,8,MTX,MG (TSVTB8) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED MINOR SIGNS OF USE. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT VERIFIED THE DEVICES DISENGAGED AS INTENDED. NO MALFUNCTION. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1241956). 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, WERE NOTED AS PART OF THE DHR. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1241956) FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. REVIEW COMPLETED UTILIZING KEYWORDS: DOES NOT DISENGAGE/RELEASE. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID NOT OCCUR AND THE REPORTED EVENT WAS UNCONFIRMED.

    Description of Event or Problem · 0

    DOCTOR REPORTED THAT MOUNT GOT STUCK AT THE IMPLANT, THE SCREW INSIDE GETS STUCK IN THE CHANNEL, SO THAT MOUNT CANNOT BE REMOVED WITHOUT REMOVING THE IMPLANT. THEN IMPLANT BED HAD TO BE PREPARED FOR NEW IMPLANT OF THE SAME LENGTH. TOOTH SITE 15.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1991596 IMP,TSV,3.7,8,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVTB8 1241956 00889024019966

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male