BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DO NOT USE - OSSEOTITE XP IMPLANT 4/5 X 13MM

    MDR report key: 11395568 · Received March 1, 2021

    Report

    Report Number
    0001038806-2021-00366
    Event Type
    Injury
    Date Received
    March 1, 2021
    Date of Event
    November 13, 2020
    Report Date
    March 1, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). 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. A SUMMARY INVESTIGATION HAS ALSO 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 EVENT, AN ADDITIONAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAS HX/O INFECTION SINCE (B)(6) 2020. GENERAL DENTIST SENT PATIENT BACK HERE TO FOLLOW UP. BONE LOSS IS NECROTIC. HAD TO REMOVED IMPLANT AT TOOTH LOCATION # 6. PATIENT TO RETURN IN 1 MONTH TO DECIDE ON TREATMENT. AS A RESULT OF THIS EVENT, NO INJURY TO THE PATIENT REPORTED. SYMPTOMS AS A RESULT OF THE EVENT: INFECTION, BONE LOSS, ABSCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292908 DO NOT USE - OSSEOTITE XP IMPLANT 4/5 X 13MM DENTAL IMPLANT DZE BIOMET 3I 495581

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention