BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5 X 45MM MULTIAXIAL SCREW

    MDR report key: 11680443 · Received April 16, 2021

    Report

    Report Number
    3012447612-2021-00122
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    November 16, 2020
    Report Date
    April 16, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    MNH
    UDI-DI
    00880304925182
    PMA / PMN Number
    K061441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CONFIRMED FOR ONE RETURNED POLARIS SCREW FOR THE FAILURE OF LACKING POLYAXIAL MOTION, CAUSING MATING ISSUES. MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW. DEVICE EVALUATION: VISUAL INSPECTION REVEALED MINOR SCRATCHES ON THE TULIP, BUT NO SIGNS OF DAMAGE. A FUNCTIONAL EXAMINATION SHOWS THAT THE TULIP IS FROZEN AND THERE IS NO POLYAXIAL MOVEMENT OF THE TULIP HEAD. THE COMPLAINT IS NOT CONFIRMED FOR A CRACK, HOWEVER IT IS CONFIRMED FOR NO POLYAXIAL MOTION OF THE TULIP HEAD. POTENTIAL CAUSE: ROOT CAUSE WAS UNABLE TO BE DETERMINED. THIS EVENT COULD POSSIBLY BE ATTRIBUTED TO FORCES APPLIED AT AN OFF-AXIS ANGLE. DHR REVIEW AND RELATED ACTIONS: PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. NO ACTIONS REQUIRED. THIS EVENT IS NOT RELATED TO ANY CURRENT ACTIONS OR RECALLS OR PRODUCT HOLDS. DEVICE USE AND COMPATIBILITY: THIS DEVICE IS USED FOR TREATMENT. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCT LINES; THEREFORE A COMPATIBILITY REVIEW IS NOT APPLICABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF NEW INFORMATION IS RECEIVED THAT CHANGES THE INFORMATION PROVIDED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE POLARIS SCREW WAS FOUND TO HAVE A CRACK AT THE END OF THE SCREW CONNECTION DURING THE OPERATION. ANOTHER SCREW WAS USED TO COMPLETE THE OPERATION. NO PATIENT IMPACT WAS REPORTED. HOWEVER, UPON DEVICE EVALUATION BY THE MANUFACTURER, THE SCREW WAS FOUND TO HAVE LOST ITS POLYAXIAL MOTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    580281 6.5 X 45MM MULTIAXIAL SCREW EBI 5.5 HELICAL FLANGE SPINAL SYSTEM MNH ZIMMER BIOMET SPINE INC. N/A J6482766 00880304925182

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR