BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSSEOTITE® IMPLANT 3.75 X 10MM

    MDR report key: 12287356 · Received August 6, 2021

    Report

    Report Number
    0001038806-2021-01455
    Event Type
    Injury
    Date Received
    August 6, 2021
    Date of Event
    April 8, 2021
    Report Date
    December 13, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K063286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    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. G3: DATE RECEIVED BY MANUFACTURER. G6: TYPE OF REPORT. H1: TYPE OF REPORTABLE EVENT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER. H6: ADVERSE EVENT PROBLEM. H10: ADDITIONAL NARRATIVE. ONE OSSEOTITE® IMPLANT 3.75 X 10MM (OSS310) AND ONE OSSEOTITE® IMPLANT 3.75 X 11.5MM (OSS311) WERE RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED SIGNIFICANT SIGNS OF USE AND FRACTURING AT THE MIDDLE THREADS. BONE DEBRIS ON THE EXTERNAL THREADS. DEVICE HISTORY RECORD (DHR) WAS NOT AVAILABLE ELECTRONICALLY FOR THE SUBJECT LOT NUMBER (229926 AND 232154). THEREFORE, IT COULD NOT BE FURTHER REVIEWED AT THE TIME OF THE INVESTIGATION. A NOTIFICATION HAS BEEN SENT TO MANUFACTURING TO REQUEST THE DHR FOR REVIEW. THE PCE WILL BE REOPENED AND UPDATED IF THERE IS ANY INDICATION OF NONCONFORMANCE, OR ANY POSSIBLE MANUFACTURING ISSUE RELATED TO THE REPORTED EVENT. COMPLAINT HISTORY REVIEW BY LOT NUMBERS (229926 AND 232154) WAS PERFORMED FOR SIMILAR EVENT USING KEYWORD FRACTURE IMPLANT AND NO COMPLAINT ABOUT NONCONFORMING PRODUCTS WAS IDENTIFIED. THEREFORE, BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION HAS OCCURRED AND THE REPORTED EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4).

    Description of Event or Problem · 1

    DOCTOR REPORTED IMPLANT FRACTURE AT TOOTH SITES 24 AND 26.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1183582 OSSEOTITE® IMPLANT 3.75 X 10MM DENTAL IMPLANT DZE BIOMET 3I 229926

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention