BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DO NOT USE - OSSEOTITE XP IMPLANT 4/5 X 11.5MM

    MDR report key: 10612644 · Received October 1, 2020

    Report

    Report Number
    0001038806-2020-01468
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    January 27, 2020
    Report Date
    January 22, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS ARE BEING REPORTED: H6: METHOD CODE WAS ADDED: 4109. H6: RESULTS CODE WAS ADDED: 3252. H6: CONCLUSIONS CODE WAS ADDED: 4307. THE REPORTED DEVICE WAS RECEIVED FOR EVALUATION. THE REPORTED CONDITION OF A FRACTURED IMPLANT WAS CONFIRMED. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THE IMPLANT FRACTURED AT THE TOP COLLAR REGION. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. THE STERILIZATION OPERATION RECORD WAS NOT ELECTRONICALLY AVAILABLE FOR THE SUBJECT LOT NUMBER (192608) THUS COULD NOT BE FURTHER REVIEWED AT THE TIME OF INVESTIGATION. A NOTIFICATION TO MANUFACTURING HAS BEEN SENT AND REQUESTED TO PULL THE FULL PAPER DHR FOR REVIEW. THE PCE WILL BE REOPENED AND UPDATED IF THERE IS ANY INDICATION OF NON-CONFORMANCE OR ANY POSSIBLE MANUFACTURING ISSUE RELATED TO THE REPORTED EVENT. SINCE STERILIZATION OPERATION NUMBER WAS NOT AVAILABLE, A TIP QA NC DATABASE WAS USED FOR NON-CONFORMANCES RELATED TO THE REPORTED EVENT AND SUBJECT LOT NUMBER. NO NON-CONFORMANCES WERE FOUND FOR THE SUBJECT LOT NUMBER. A COMPLAINT HISTORY REVIEW WAS COMPLETED FOR THE REPORTED DEVICE LOT FOR SIMILAR EVENT AND NO OTHER COMPLAINT WAS IDENTIFIED. A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO ADDITIONAL OR CORRECTED INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET (B)(4). INITIAL REPORTER¿S TITLE IS NOT PROVIDED / UNKNOWN.

    Description of Event or Problem · 1

    DOCTOR REPORTS THAT THE OS4511 IMPLANT FRACTURED. THE IMPLANT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078815 DO NOT USE - OSSEOTITE XP IMPLANT 4/5 X 11.5MM DENTAL IMPLANT DZE BIOMET 3I 192608

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention