BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPL TAPERED SCR-V HA 6MM 5.7MM 10MM

    MDR report key: 12406634 · Received September 1, 2021

    Report

    Report Number
    0002023141-2021-02383
    Event Type
    Malfunction
    Date Received
    September 1, 2021
    Date of Event
    August 9, 2021
    Report Date
    February 2, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019454
    PMA / PMN Number
    K061410
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE IMPL TAPERED SCR-V HA 6MM 5.7MM 10MM (TSV6H10) WAS RETURNED FOR INVESTIGATION (IMAGES 1 - 3). VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THAT THE IMPLANT WAS RETURNED WITHOUT THE ORIGINAL PACKAGING/VIALS. SIGNS OF USE WAS ALSO IDENTIFIED ON THE IMPLANT. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. PATIENT PRE-EXISTING CONDITIONS, TOOTH LOCATION, PLACEMENT DURATION AND X-RAY IMAGE WERE IRRELEVANT TO THIS INVESTIGATION. PICTURE IMAGE WAS NOT PROVIDED BY THE CUSTOMER. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW FOR THE LOT (1242729) 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. THE DHR WAS FURTHER REVIEWED TO VERIFY THE PACKAGING PROCESS. NO MALFUNCTION OR NONCONFORMANCE WAS IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1242729) FOR SIMILAR EVENTS AND NO OTHER COMPLAINTS WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, THE REPORTED MALFUNCTION COULD NOT BE VERIFIED. ADDITIONALLY, THE REPORTED EVENT/COOB COULD NOT BE VERIFIED SINCE THE CONDITION OF THE PRODUCT/PACKAGING AS RECEIVED BY THE CUSTOMER WAS UNKNOWN/NONVERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT G3: DATE RECEIVED BY MANUFACTURER G6: CHECKED "FOLLOW-UP" H2: CHECKED FOLLOW-UP TYPE H3: CHANGED "NO" TO "YES" H6: ENTERED EVALUATION CODES H10: ADDED MANUFACTURER NARRATIVE

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). K011028, K013227.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANT WAS LOOSE IN THE VIAL WHEN ATTEMPTING TO REMOVE IT AND THE LOSS OF STERILITY OCCURRED. JUST USED ANOTHER IMPLANT FROM STOCK. TOOTH # 19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1308629 IMPL TAPERED SCR-V HA 6MM 5.7MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSV6H10 1242729 00889024019454

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female