BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DO NOT USE-NANOTITE TM CERTAIN IMPLANT 5 X 13MM

    MDR report key: 11119212 · Received January 5, 2021

    Report

    Report Number
    0001038806-2021-00019
    Event Type
    Injury
    Date Received
    January 5, 2021
    Date of Event
    December 2, 2020
    Report Date
    March 19, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    UDI-DI
    00844868011415
    PMA / PMN Number
    K051461
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY CORRECTED DATA AND ADDITIONAL INFORMATION. ASSOCIATED LOT #943288 WAS MANUFACTURED PRIOR TO 24-SEP-2015, AS A RESULT, A UDI NUMBER IS NOT REQUIRED. THE FOLLOWING SECTIONS ARE BEING REPORTED: B4: DATE OF THIS REPORT WAS UPDATED. D4: UDI NUMBER WAS REMOVED. G3: DATE RECEIVED BY MANUFACTURER WAS UPDATED. G6: TYPE OF REPORT WAS UPDATED. H2: TYPE OF FOLLOW UP WAS UPDATED. H6: COMPONENT CODE WAS ADDED: 4755. H10: NARRATIVE/DATA WAS UPDATED.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). WEIGHT UNKNOWN / NOT PROVIDED A SUMMARY INVESTIGATION HAS BEEN COMPLETED FOR BONE LOSS 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 BONE LOSS HAVE NOT IDENTIFIED ANY SIGNALS INDICATING POTENTIAL NON-CONFORMANCES AFFECTING THE MANUFACTURING AND STERILIZATION PROCESSES. FURTHERMORE, THE PROBABILITY OF MANUFACTURING OR DESIGN DEFECTS THAT MIGHT LEAD TO BONE LOSS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO BONE LOSS AROUND IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15817 DO NOT USE-NANOTITE TM CERTAIN IMPLANT 5 X 13MM DENTAL IMPLANT DZE BIOMET 3I NIOSS513 943288 00844868011415

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention