BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,3.7,13,MTX,MG

    MDR report key: 10358452 · Received August 3, 2020

    Report

    Report Number
    0002023141-2020-01166
    Event Type
    Injury
    Date Received
    August 3, 2020
    Report Date
    October 16, 2020
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    PMA / PMN Number
    K101977
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING ITEM (TSVTB13) AND LOT NUMBER (1223374). DHR REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1223374). 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 (1223374) FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. 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

    ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING ITEM (TSVTB13) AND LOT NUMBER (1223374).

    Additional Manufacturer Narrative · 1

    SUMMARY INVESTIGATION (B)(4). PATIENT ID UNKNOWN. AGE & DOB UNKNOWN. GENDER UNKNOWN. WEIGHT UNKNOWN. ETHNICITY UNKNOWN. EVENT DATE UNKNOWN. IMPLANT LOT # & UDI # UNKNOWN. REPORTS LAST NAME & TITLE UNKNOWN. MANUFACTURES DATE UNKNOWN. 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. SUMMARY INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823466 IMP,TSV,3.7,13,MTX,MG DENTAL IMPLANT DZE ZIMMER DENTAL 1223374

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention