BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM

    MDR report key: 15422145 · Received September 14, 2022

    Report

    Report Number
    0002023141-2022-02396
    Event Type
    Injury
    Date Received
    September 14, 2022
    Report Date
    February 6, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020047
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). MA/510K: K011028, K013227.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP".

    Additional Manufacturer Narrative · 0

    ONE (1) IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM (TSVWB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNS OF USE. THERE WAS BONE DEBRIS ON THREADS. A REMOVAL TOOL WAS STUCK TO THE IMPLANT; HOWEVER, IT DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. THE CONDITION OF THE TOP/COLLAR OF THE IMPLANT WAS UNKNOWN. ONE (1) IMPLANT REMOVER 5.0 X 15MM, WIDE 5.0, SHORT, 1 EA (IR515) WAS ALSO RETURNED. IT WAS MANUFACTURED BY DOWELL DENTAL PRODUCTS, INC (SUPPLIER ID: (B)(4)) AND WILL BE SENT TO THE SUPPLIER FOR INVESTIGATION. THIS INVESTIGATION ADDRESSED ONLY THE ZIMMER IMPLANT AND THE RELATED EVENT (FRACTURE) USING APPLICABLE INSTRUCTIONS FOR USE, RISK FILES AND OTHER AVAILABLE INFORMATION. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. A PRE-EXISTING CONDITION WAS NOT NOTED ON THE PER FORM AND THE BONE DENSITY WAS UNKNOWN. THE REPORTED DEVICE WAS LOCATED ON AN TOOTH LOCATION # 31 (UNIVERSAL) AND WAS USED FOR APPROXIMATELY 6 YEARS AND 5 MONTHS. THE CUSTOMER DID NOT PROVIDE ANY IMAGES FOR THE REPORTED EVENT. APPROPRIATE DOCUMENTATION WAS REVIEWED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER 63254557. 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 WAS 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 63254557 FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. DECEMBER POST MARKET TRENDING WAS REVIEWED AND THERE WERE NO ACTIONABLE EVENTS OR CORRECTIVE ACTIONS FOR THE REPORTED EVENT OR PRODUCT. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION COULD NOT BE VERIFIED AND THE REPORTED EVENT WAS NON-VERIFIABLE. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: G6: CHECKED "FOLLOW-UP". H3: CHANGED "NO" TO "YES".

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THE IMPLANT WAS REMOVED DUE TO FRACTURE.CUSTOMER DIDN'T USE ANOTHER DEVICE TO COMPLETE THE PROCEDURE.NO OTHER SYMPTOMS WERE REPORTED.PATIENT WONT RETURN FOR AN ADDITIONAL APPOINTMENT. TOOTH#31.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT REMOVAL TOOL IR515 WAS STUCK TO THE IMPLANT AFTER THEY REMOVED THE IMPLANT, SO THEY SENT THE PRODUCT BACK TOGETHER.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2675322 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB10 63254557 00889024020047

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention