BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAIN® TITANIUM LARGE HEXED SCREW

    MDR report key: 12171991 · Received July 15, 2021

    Report

    Report Number
    0001038806-2021-01266
    Event Type
    Injury
    Date Received
    July 15, 2021
    Date of Event
    March 11, 2021
    Report Date
    November 16, 2021
    Manufacturer
    BIOMET 3I
    Product Code
    DZE
    PMA / PMN Number
    K972444
    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). TWO CERTAIN® TITANIUM LARGE HEXED SCREW (2X ILRGHT) WERE RETURNED FOR INVESTIGATION. VISUAL INSPECTION OF THE AS RETURNED PRODUCT IDENTIFIED WORN MARKINGS DUE TO USAGE AND A FRACTURES AT THE THREADS. DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED, AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED PRODUCT IS NOT AVAILABLE. ZIMMER BIOMET QUALITY MANAGEMENT SYSTEM (QMS) HAS CONTROLS IN PLACE TO ENSURE THE DISTRIBUTION OF CONFORMING PRODUCT WITHIN SPECIFICATIONS. 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-CONFORMANCES/CAPA/HHE/D/IE/PRODUCT HOLDS FOR THE REPORTED DEVICE RELATED TO THE REPORTED EVENT USING KEYWORD FRACTURE SCREW. BASED ON THE AVAILABLE INFORMATION, DEVICE MALFUNCTION DID OCCUR 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). PATIENT IDENTIFIER UNKNOWN / NOT PROVIDED. WEIGHT UNKNOWN / NOT PROVIDED. PREMARKET IDENTIFICATION PMA/510(K) NUMBER K072642. DEVICE MANUFACTURER DATE UNKNOWN / NOT PROVIDED.

    Description of Event or Problem · 1

    DOCTOR HAS REPORTED BOTH SCREWS FRACTURED AND WERE REMOVED FROM THE IMPLANTS. IMPLANTS ARE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070371 CERTAIN® TITANIUM LARGE HEXED SCREW DENTAL SCREW DZE BIOMET 3I

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female