BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMP, TSV, 4.7,10,MTX,MC,MG,HA

    MDR report key: 12804232 · Received November 12, 2021

    Report

    Report Number
    0002023141-2021-03252
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    June 11, 2021
    Report Date
    February 2, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024344143
    PMA / PMN Number
    K101880
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). ADDITIONAL 510(K) NUMBER IS K133339.

    Additional Manufacturer Narrative · 0

    ONE IMP, TSV, 4.7,10, MTX, MC, MG, HA (TSVMWH10) AND MOUNT WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED THAT THE DEVICES WERE ENGAGED. FUNCTIONAL TESTING WAS PERFORMED AND IT WAS NOTICED THAT THE DEVICES COULD NOT DISENGAGE. PRE-EXISTING CONDITION NOTED ON THE PER WAS MODERATE BONE DENSITY ¿ TYPE II. THE DEVICES WERE INTENDED FOR TOOTH #19 (UNIVERSAL). X-RAY OR PICTURE EVALUATION: X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENT REVIEWED: INSTRUCTIONS FOR USE - TAPERED SCREW-VENT AND TRABECULAR METAL IMPLANTS, IFU4869 REV 9-10/19. INFORMATION IDENTIFIED: WARNINGS, PRECAUTIONS AND BREAKAGE. PER THE APPLICABLE IFU, IT IS STATED THAT IMPROPER TECHNIQUE CAN CAUSE DEVICE FAILURE. DHR REVIEW: DHR REVIEW FOR THE LOT (1238024) 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. LOT WAS INSPECTED AND PASSED ALL ACCEPTANCE CRITERIA BY QA. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1238024) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: FUNCTIONAL: DOES NOT DISENGAGE/RELEASE) AND 1 OTHER COMPLAINT WAS IDENTIFIED UNDER (B)(4). POST MARKET TRENDING REVIEW: DECEMBER 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

    IT WAS REPORTED THAT THE IMPLANT MOUNT WAS UNABLE TO BE REMOVED FROM THE IMPLANT. THE PROCEDURE WAS COMPLETED USING ANOTHER IMPLANT. TOOTH #19.

    Description of Event or Problem · 0

    THERE IS NO UPDATE TO THE ORIGINAL COMPLAINT DESCRIPTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1705143 IMP, TSV, 4.7,10,MTX,MC,MG,HA DENTAL IMPLANT DZE ZIMMER DENTAL TSVMWH10 1238024 00889024344143

    Patients

    Seq Age Sex Outcome Treatment
    1 Male