BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.5 X 40MM MULTIAXIAL SCREW

    MDR report key: 7026784 · Received November 13, 2017

    Report

    Report Number
    3012447612-2017-00634
    Event Type
    Malfunction
    Date Received
    November 13, 2017
    Date of Event
    October 30, 2017
    Report Date
    November 13, 2017
    Manufacturer
    ZIMMER BIOMET SPINE INC.
    Product Code
    MNH
    PMA / PMN Number
    PK061441
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT NUMBER IS UNKNOWN; THEREFORE THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TULIP HEAD SNAPPED OFF A PEDICLE SCREW DURING SURGERY. THE PEDICLE SCREW WAS REMOVED AND REPLACED WITH AN ALTERNATIVE SCREW. THERE WERE NO REPORTS OF PATIENT IMPACTS ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804339 6.5 X 40MM MULTIAXIAL SCREW EBI 5.5 HELICAL FLANGE SPINAL SYSTEM MNH ZIMMER BIOMET SPINE INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1