BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM

    MDR report key: 14731707 · Received June 17, 2022

    Report

    Report Number
    0002023141-2022-01556
    Event Type
    Injury
    Date Received
    June 17, 2022
    Date of Event
    February 14, 2022
    Report Date
    November 28, 2022
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019508
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER (IN CONFIDENCE) UNKNOWN / NOT PROVIDED. GENDER UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. EXPIRATION DATE UNKNOWN / NOT PROVIDED. EMAIL ADDRESS UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION K011028 AND K013227.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER: (B)(4). THE FOLLOWING FIELDS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. B5: DESCRIBE EVENT OR PROBLEM. D4: ADDITIONAL DEVICE INFORMATION. G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVE. AN IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM (TSVB10) AND AN UNKNOWN ZIMMER SCREW WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCTS IDENTIFIED BONE / TISSUE ATTACHED TO THE IMPLANT EXTERNAL THREADS. FRACTURE AT THE COLLAR AND SCREW FRACTURE FOUND INSIDE. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER: (1243055). 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: (1243055) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. 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 AT TOOTH LOCATION 46 WAS REMOVED DUE RO FRACTURE AT THE NECK OF THE IMPLANT.

    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
    193786 IMPL TAPERED SCR-V SBM 3.7MM 3.5MM 10MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB10 1243055 00889024019508

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Unknown Required Intervention