BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 9600099 · Received January 17, 2020

    Report

    Report Number
    0001038806-2020-00150
    Event Type
    Injury
    Date Received
    January 17, 2020
    Date of Event
    June 17, 2019
    Report Date
    March 19, 2020
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K972444
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). ONE CERTAIN® TITANIUM LARGE HEXED SCREW (ILRGHT) WAS RETURNED FOR INVESTIGATION. VISUAL EVALUATION OF THE AS RETURNED PRODUCT IDENTIFIED THAT SCREW FRACTURED NEAR THE START OF THE THREADS. FUNCTIONAL TESTING TO RECREATE THE REPORTED EVENT COULD NOT BE PERFORMED DUE TO THE NATURE OF THE DEVICE AND EVENT. NO PRE-EXISTING CONDITIONS WERE NOTED ON THE PER. THE PATIENT HAD UNKNOWN BONE DENSITY. THE REPORTED DEVICES WERE USED ON UNKNOWN TEETH AND WERE USED FOR AN UNKNOWN DURATION. THE CUSTOMER DID NOT PROVIDE PICTURES OR X-RAY IMAGES. DEVICE HISTORY RECORD REVIEWS AND COMPLAINT HISTORY REVIEWS BY LOT NUMBER COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED DEVICE ISNOT AVAILABLE. A COMPLAINT HISTORY REVIEW BY ITEM NUMBER WAS CONDUCTED FOR THE (ILRGHT) DATING BACK TO 12 MONTHS FROM NOW. THE COMPLAINT HISTORY REVIEW REVEALED THAT THERE ARE NO EXISTING NON-CONFORMANCE/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICES RELATED TO THE REPORTED EVENT. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT. G7: TYPE OF REPORT, FOLLOW-UP NUMBER. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER: CHANGE ¿NO' TO 'YES'. H6: EVALUATION CODES. H10: ADDITIONAL NARRATIVE.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    ZIMMERBIOMET COMPLAINT NUMBER (B)(4). PMA/510(K): K072642.

    Description of Event or Problem · 1

    IT WAS REPORTED SCREW FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66292 CERTAIN® TITANIUM LARGE HEXED SCREW DENTAL SCREW DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention