BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 13042096 · Received December 20, 2021

    Report

    Report Number
    0002023141-2021-03676
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    May 30, 2021
    Report Date
    May 2, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024020047
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). THE FOLLOWING SECTIONS HAVE BEEN UPDATED: H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. ONE TAPERED SCREW-VENT IMPLANT (TSVWB10) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED NO DAMAGE OR SIGNS OF MALFUNCTION. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED EVENT (ALLERGIC REACTION). FOLLOWING DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS (FILE: DRAWING), THE DEVICE WAS IDENTIFIED TO BE WITHIN DESIGN SPECIFICATIONS. PRE-EXISTING CONDITION NOTED ON THE PER IS 'MODERATE BONE DENSITY ¿ TYPE II'. THE REPORTED DEVICE HAD BEEN PLACED ON TOOTH #36 (FDI) FOR APPROXIMATELY 5 DAYS. X-RAY & PICTURE EVALUATION: X-RAY AND PICTURE IMAGES WERE NOT PROVIDED. REVIEW OF APPROPRIATE DOCUMENTATION: DOCUMENTS REVIEWED: INSTRUCTIONS FOR USE - TAPERED SCREW-VENT AND TRABECULAR METAL IMPLANTS, IFU4869 REV 9-10/19. INFORMATION IDENTIFIED: CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND ADVERSE EFFECTS. PER THE APPLICABLE IFU, LOCAL AND GENERALIZED ALLERGIC REACTIONS ARE LISTED AS ADVERSE EFFECTS. ALSO, IT IS STATED THAT SOME ADVERSE EFFECTS MAY OCCUR AS A RESULT OF IATROGENIC FACTORS AND HOST RESPONSES. DHR REVIEW: DHR REVIEW FOR THE LOT (1242120) 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. STERILIZATION RECORD REVIEW: ALL STERILIZATION ACTIVITIES WERE CONDUCTED WITH NO NONCONFORMITIES PER STERILIZATION RECORDS (OP160). ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCTS WITHIN SPECIFICATIONS. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1242120) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: MEDICAL: ALLERGIC REACTION) AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: FEBRUARY 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 NOT OCCUR. THE REPORTED EVENT COULD NOT BE VERIFIED AS THE EXACT DETAILS OF EVENT AND PATIENT CONDITIONS WERE UNKNOWN/NONVERIFIABLE.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PMA/510(K) NUMBER: K011028 AND K013227.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THE IMPLANTWAS REMOVED DUE TO EXCESSIVE ALLERGIC REACTION. PATIENT FELT PAIN AND THE SITE PRESENTED EDEMA AND INFLAMMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945976 IMPL TAPERED SCR-V SBM 4. 7MM 4.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVWB10 1242120 00889024020047

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention