BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUG

    MDR report key: 11841035 · Received May 18, 2021

    Report

    Report Number
    3012447612-2021-00179
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 22, 2021
    Report Date
    June 10, 2021
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    MNH
    UDI-DI
    00880304925816
    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 OF THE DEVICES SHOWS THAT ALL FOUR HAVE STRIPPED THREADS. POTENTIAL CAUSE: THE CAUSE OF THE DAMAGE CANNOT BE DETERMINED AT THIS TIME SINCE THERE IS NO INFORMATION AVAILABLE REGARDING HOW THE PLUGS WAS BEING USED OR HANDLED AT THE TIME OF THE DAMAGE. DHR REVIEW: PER DHRS REVIEW, THE PARTS WERE LIKELY CONFORMING WHEN IT LEFT ZIMMER BIOMET CONTROL. DEVICE USE AND COMPATIBILITY: THIS DEVICES ARE USED FOR TREATMENT. 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 · 0

    IT WAS REPORTED THAT FOUR PLUGS WITH STRIPPED THREADS WERE FOUND DURING SURGERY. THE PLUGS WERE REMOVED AND THE SAME TYPE OF PLUGS WERE USED TO COMPLETE THE OPERATION. THERE WAS NO REPORTED PATIENT IMPACT. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(6). WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. 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. REFERENCE REPORTS 3012447612-2021-00182.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR PLUGS WITH STRIPPED THREADS WERE FOUND DURING SURGERY. THE PLUGS WERE REMOVED AND THE SAME TYPE OF PLUGS WERE USED TO COMPLETE THE OPERATION. THERE WAS NO REPORTED PATIENT IMPACT. THIS IS REPORT ONE OF FOUR FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735919 PLUG EBI 5.5 HELICAL FLANGE SPINAL SYSTEM MNH ZIMMER BIOMET SPINE INC. N/A J6823790 00880304925816

    Patients

    Seq Age Sex Outcome Treatment
    1