BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,6.0,10,MTX,MG

    MDR report key: 15383692 · Received September 8, 2022

    Report

    Report Number
    0002023141-2022-02346
    Event Type
    Injury
    Date Received
    September 8, 2022
    Report Date
    February 8, 2023
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019874
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). WEIGHT UNKNOWN / NOT PROVIDED. ADDITIONAL PMA/510(K) NUMBER ¿ K101880. 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: B4: DATE OF THIS REPORT WAS UPDATED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H3: DEVICE EVALUATED BY MANUFACTURER WAS UPDATED. H6: TYPE OF INVESTIGATION CODE WAS ADDED: 3331 AND 4114. H10: NARRATIVE/DATA WAS UPDATED. DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1252707). 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 (OP#150) 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 (1252707) FOR SIMILAR EVENTS AND TWO (2) OTHER RELEVANT COMPLAINTS WERE IDENTIFIED. INVESTIGATION HAS IDENTIFIED THAT THE MOST LIKELY PROBABLE CAUSES ARE RELATED TO PATIENT BIOLOGICAL FACTORS/CONDITION AND SURGICAL TECHNIQUE. AS DOCUMENTED IN THE SUMMARY INVESTIGATION, CONTRIBUTING FACTORS FOR THE REPORTED EVENT LIKELY EXIST OUTSIDE OF ZIMMER BIOMET 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.

    Description of Event or Problem · 0

    DURING A ROUTINE CHECK-UP, THE PATIENT REPORTED HAVING MULTIPLE DRAINAGE INFECTIONS FROM AROUND THE IMPLANT IN THE LAST FEW MONTHS FOR WHICH ANTIBIOTICS WERE TAKEN (PRESCRIBED BY ANOTHER PHYSICIAN). AT THAT TIME OF THIS EVENT, THE IMPLANT REMAINED IMPLANTED. FOLLOW-UP WITH THE CUSTOMER REVEALED THAT THE PATIENT IS A PHYSICIAN AND SELF-PRESCRIBED THE ANTIBIOTICS. NO ADDITIONAL INFORMATION IS KNOWN. NOTE: SEE MFR REPORT: 0002023141-2022-02065 FOR THE EVENT WHEN THE IMPLANT WAS REMOVED.

    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
    2108105 IMP,TSV,6.0,10,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL TSVT6B10 1252707 00889024019874

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention