BEUDAMED
    FDA Adverse Event Injury Summary report: N

    (01)00844868029717(17)210930(10)2016091064

    MDR report key: 17289592 · Received July 10, 2023

    Report

    Report Number
    0001038806-2023-01259
    Event Type
    Injury
    Date Received
    July 10, 2023
    Date of Event
    June 5, 2023
    Report Date
    July 9, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868029717
    PMA / PMN Number
    K122300
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMVIE COMPLAINT (B)(4).ADDITIONAL 510(K) NUMBER IS K101880. 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. SUMMARY INVESTIGATION.

    Description of Event or Problem · 0

    CLINICIAN REPORTED PATIENT COMPLAINING IMPLANT CAUSING PAIN AND BECAME LOOSE. SITE WAS GRAFTED WHEN IMPLANT WAS PLACE WITH ALLOGRAFT. THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208280 (01)00844868029717(17)210930(10)2016091064 DENTAL IMPLANT DZE BIOMET 3I BOST611 2016091064 00844868029717

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention