BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMP,TSV,4.1MM,SBM,11.5

    MDR report key: 12222600 · Received July 24, 2021

    Report

    Report Number
    0002023141-2021-01913
    Event Type
    Injury
    Date Received
    July 24, 2021
    Date of Event
    June 6, 2021
    Report Date
    November 16, 2021
    Manufacturer
    ZIMMER DENTAL
    Product Code
    DZE
    UDI-DI
    00889024019232
    PMA / PMN Number
    K072589
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. D9: DEVICE AVAILABILITY. 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. DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR THE SUBJECT LOT NUMBER (1223365). 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 RECORDS (OP150) WERE 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 (1223365) FOR SIMILAR EVENTS (COMPLAINT CATEGORY KEYWORDS: INFECTION, BONE LOSS, PERI-IMPLANTITIS) AND NO OTHER COMPLAINT WAS IDENTIFIED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). PATIENT WEIGHT: NOT PROVIDED. FAX NUMBER, POST OFFICE OR ZIP CODE: NOT PROVIDED. A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR PERI-IMPLANTITIS EVENTS RECOGNIZING THAT A DEFINITIVE ROOT CAUSE CANNOT BE IDENTIFIED DUE TO A WIDE RANGE OF EXTERNAL FACTORS (NON-DESIGN OR MANUFACTURING RELATED), INCLUDING MEDICAL CONDITIONS (E.G., DIABETES, POOR BONE QUALITY, ETC.) / PATIENT HABITS (E.G., SMOKING) AND SURGICAL TECHNIQUE. PREVIOUSLY COMPLETED INVESTIGATIONS FOR THESE EVENTS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF A MANUFACTURING OR DESIGN DEFECT THAT MIGHT LEAD TO PERI-IMPLANTITIS OCCURRING AND ESCAPING THE AVAILABLE DETECTIONS HAS BEEN ASSESSED AND FOUND REMOTE AND ALMOST NONEXISTENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED WHICH INDICATES THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED. H3 OTHER TEXT : SUMMARY INVESTIGATION

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANT IN TOOTH LOCATION #28 WAS REMOVED DUE TO PERI-IMPLANTITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1119719 IMP,TSV,4.1MM,SBM,11.5 DENTAL IMPLANT DZE ZIMMER DENTAL TSV4B11 1223365 00889024019232

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention