BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM

    MDR report key: 15915372 · Received December 5, 2022

    Report

    Report Number
    0002023141-2022-03016
    Event Type
    Injury
    Date Received
    December 5, 2022
    Report Date
    April 27, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019515
    PMA / PMN Number
    K061410
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. DATE OF EVENT UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER ¿K013227. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR INFECTION EVENTS IDENTIFYING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO THE WIDE RANGE OF EXTERNAL (NON-DESIGN/ NON-MANUFACTURING RELATED) FACTORS POTENTIALLY IMPACTING THE STERILITY OF THE IMPLANT AND ITS ENVIRONMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE INFECTION EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND DEVICE EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: H6: TYPE OF INVESTIGATION CODE WAS ADDED: 3331. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1241364). 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. STERILIZATION RECORD (B)(4) WAS REVIEWED AND VERIFIED TO HAVE PASSED ALL STERILIZATION ACTIVITIES WITH NO ISSUES OR NONCONFORMITIES IDENTIFIED. COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER (1241364) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. AS DOCUMENTED IN THE SUMMARY INVESTIGATION, CONTRIBUTING FACTORS FOR THIS REPORTED EVENT LIKELY EXIST OUTSIDE OF ZIMVIE CONTROL, INCLUDING THOSE RELATED TO PATIENT BIOLOGICAL FACTORS/CONDITION AND SURGICAL TECHNIQUE. BASED ON THE SUMMARY INVESTIGATION, NO MALFUNCTION OCCURRED UPON INVESTIGATION. THE REPORTED EVENT REMAINS NON-VERIFIABLE AS IT IS A MEDICAL CONDITION.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED DATA AND ADDITIONAL INFORMATION. CORRECTION: THE REPORTED DEVICE WAS NOT RETURNED FOR EVALUATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. D9: PRODUCT AVAILABILITY WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: NOT RETURNED TO MANUFACTURER WAS UPDATED. H6: TYPE OF INVESTIGATION CODE WAS ADDED: 4114. H10: NARRATIVE/DATA WAS UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH LOCATION #46 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815786 IMPL TAPERED SCR-V MTX 3.7MM 3.5MM 11.5MM DENTAL IMPLANT DZE ZIMMER DENTAL TSVB11 1241364 00889024019515

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention