BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE WAX WHITE

    MDR report key: 16416418 · Received February 22, 2023

    Report

    Report Number
    16416418
    Event Type
    Malfunction
    Date Received
    February 22, 2023
    Date of Event
    February 3, 2023
    Report Date
    February 13, 2023
    Manufacturer
    SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V.
    Product Code
    MTJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGICAL SPECIALTIES BONE WAX WHITE (REF 903; LOT #C318TWO; EXP 02/17/2027). THIS BONE WAX WAS COMPLETELY DRY AND BRITTLE WHEN OPENED ONTO THE STERILE FIELD. WE OPENED FOUR MORE PACKAGES OF THE SAME LOT #. ALL PACKAGES WERE DRY AND BRITTLE. WE ENDED UP HAVING TO OPEN A NEW BOX WITH A DIFFERENT LOT # TO GET A GOOD PLIABLE WAX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1227475 BONE WAX WHITE WAX,BONE MTJ SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V. 903 C318TWO

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown