BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET CORONAL BENDERS

    MDR report key: 12106626 · Received July 2, 2021

    Report

    Report Number
    12106626
    Event Type
    Malfunction
    Date Received
    July 2, 2021
    Date of Event
    October 1, 2020
    Report Date
    June 22, 2021
    Manufacturer
    BIOMET SPINE LLC
    Product Code
    MNH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS HAVING A POSTERIOR SPINAL FUSION. DURING THE PROCEDURE, THE SURGEON WAS USING AN INSTRUMENT CALLED CORONAL BENDERS. WHILE USING THESE INSTRUMENTS, TWO PIECES SNAPPED OFF OF ONE OF THESE CORONAL BENDERS. DURING INSPECTION OF THE PATIENT'S OPEN INCISION, WITH HELP USING THE C-ARM, THE 2 PIECES WERE LOCATED AND REMOVED FROM THE PATIENT. THE SURGEON STATED THAT ALL PIECES WERE FOUND. THE INSTRUMENT WAS REMOVED FROM USE. VENDOR REPRESENTATIVE WILL TAKE THE INSTRUMENT WITH HIM TO SEND BACK TO COMPANY. THIS INSTRUMENT WAS PART OF A REP. LOANER TRAY. THE REP. STATED THAT IT WAS MADE OF STAINLESS STEEL AND WAS PRONE TO BREAKING EASILY. HE TOOK IT AND IT HAS BEEN SENT BACK TO THE COMPANY, ZIMMER BIOMET FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004860 BIOMET CORONAL BENDERS ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION MNH BIOMET SPINE LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 7300 DA