BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM

    MDR report key: 15113339 · Received July 27, 2022

    Report

    Report Number
    0002023141-2022-01882
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    March 15, 2022
    Report Date
    December 9, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019522
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT WEIGHT NOT PROVIDED. ADDITIONAL 510(K) NUMBERS ARE K011028 AND K013227.

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ONE IMPLANT AND MOUNT WERE RETURNED FOR INVESTIGATION. THERE WERE NO ALLEGATIONS AGAINST THE MOUNT. VISUAL EVALUATION OF THE AS RETURNED PRODUCTS IDENTIFIED NO APPARENT SIGNS OF MALFUNCTION. THE DEVICE COULD NOT BE FUNCTIONALLY TESTED FOR THE REPORTED EVENT/FAILURE (BONE FRACTURE). HOWEVER, MEASUREMENTS OF THE IMPLANT WERE TAKEN USING A CALIPER (ID: (B)(6); DUE DATE: JUN 7, 2023). THROUGH DIMENSIONAL ANALYSIS AND COMPARISON TO DRAWINGS, THE DEVICE WAS DETERMINED TO BE WITHIN DESIGN SPECIFICATIONS WHEN IT LEFT ZIMVIE. PRE-EXISTING CONDITION NOTED ON THE PER WAS 'LOW BONE DENSITY ¿ TYPE III'. THE REPORTED DEVICE WAS BEING PLACED ON TOOTH 25 (FDI) WHEN THE INCIDENT OCCURRED. X-RAY & PICTURE EVALUATION: X-RAY OR PICTURE IMAGES WERE NOT PROVIDED. THEREFORE, THE REPORTED EVENTS COULD NOT BE VERIFIED. 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 BREAKAGE. PER THE APPLICABLE IFU, IT IS STATED THAT IMPROPER TECHNIQUES CAN CAUSE BONE LOSS, PATIENT INJURY, PAIN AND IMPLANT FAILURE. DHR REVIEW: DHR REVIEW FOR THE LOT (1250063) 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 (1250063) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: MEDICAL: BONE FRACTURE) AND NO OTHER COMPLAINT WAS IDENTIFIED. POST MARKET TRENDING REVIEW: SEPTEMBER 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 AND DIMENSIONAL ANALYSIS, DEVICE MALFUNCTION DID NOT OCCUR. ADDITIONALLY, THE REPORTED EVENT COULD NOT BE VERIFIED SINCE IT IS A MEDICAL CONDITION, AND NO X-RAY OR PICTORIAL EVIDENCE WAS AVAILABLE (PATIENT ANATOMICAL CONDITION AND DETAILS OF EVENT WERE UNKNOWN).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE A MINOR BONE FRACTURE OCCURRED DURING IMPLANT PLACEMENT. PROCEDURE WAS ABLE TO BE COMPLETED USING ANOTHER DEVICE.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2431289 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 13MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB13 1250063 00889024019522

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention