BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FULL OSSEOTITE XP¿ IMPLANT 4/5 X 10MM

    MDR report key: 15845055 · Received November 22, 2022

    Report

    Report Number
    0001038806-2022-01800
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    October 24, 2022
    Report Date
    March 14, 2023
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063286
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). UNIQUE IDENTIFIER (UDI) NUMBER NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). COMPLAINT HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT NUMBER 220259 FOR SIMILAR EVENTS AND NO OTHER COMPLAINT WAS IDENTIFIED. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE FOS4510 DATING BACK TO 12 MONTHS FROM THE COMPLAINT NOTIFICATION DATE. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICE RELATED TO THE REPORTED EVENT. 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.

    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; D4: ADDITIONAL DEVICE INFORMATION; 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; H4: DEVICE MANUFACTURER DATE ; H6: ADVERSE EVENT PROBLEM; H10: ADDITIONAL NARRATIVE. PER VISUAL INVESTIGATION, AND CUSTOMER CONFIRMATION THE ITEM HAS BEEN UPDATED TO FOS4510.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO PERI-IMPLANTITIS AT THE IMPLANT SITE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2686384 FULL OSSEOTITE XP¿ IMPLANT 4/5 X 10MM DENTAL IMPLANT DZE BIOMET 3I 217031

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention