BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5 X 45MM MULTIAXIAL SCREW

    MDR report key: 12032081 · Received June 21, 2021

    Report

    Report Number
    3012447612-2021-00199
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 24, 2021
    Report Date
    September 22, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    MNH
    UDI-DI
    00880304925182
    PMA / PMN Number
    K061441
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: VISUAL INSPECTION REVEALED NO SIGNS OF DAMAGE. A FUNCTIONAL TEST WAS PERFORMED BY ATTEMPTING TO ROTATE THE TULIP HEAD AROUND THE SCREW SHANK, HOWEVER, THE TULIP HEAD IS RESISTANT TO MOTION AND BINDS UP. POTENTIAL CAUSE: THIS EVENT CANNOT BE ATTRIBUTED TO ANY CAUSE AT PRESENT. THE CAUSE OF THE DAMAGE CANNOT BE DETERMINED AT THIS TIME SINCE THERE IS NO INFORMATION AVAILABLE REGARDING HOW THE SCREW WAS BEING USED OR HANDLED AT THE TIME OF THE DAMAGE. DHR REVIEW: PER DHR REVIEW, THE PART WAS LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. DEVICE USE: THIS DEVICE IS USED FOR TREATMENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS A MULTIAXIAL SCREW WAS INSERTED INTO THE PATIENT THERE WAS PHYSICAL RESISTANCE. THE SURGEON USED A NEW SCREW OF THE SAME PART NUMBER TO COMPLETE THE CASE. THERE WAS NO REPORTED DELAY OR IMPACT TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS A MULTIAXIAL SCREW WAS INSERTED INTO THE PATIENT THERE WAS PHYSICAL RESISTANCE. THE SURGEON USED A NEW SCREW OF THE SAME PART NUMBER TO COMPLETE THE CASE. THERE WAS NO REPORTED DELAY OR IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929594 6.5 X 45MM MULTIAXIAL SCREW EBI 5.5 HELICAL FLANGE SPINAL SYSTEM MNH ZIMMER BIOMET SPINE INC. N/A J6844327 00880304925182

    Patients

    Seq Age Sex Outcome Treatment
    1