BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5CC HYDROSET INJECTABLE CEMENT

    MDR report key: 2479231 · Received February 24, 2012

    Report

    Report Number
    8010177-2012-00044
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Date of Event
    February 3, 2012
    Report Date
    February 3, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    GXP
    PMA / PMN Number
    K060763
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT THAT THE PRODUCT DID NOT HARDEN FAST ENOUGH COULD NOT BE CONFIRMED. ALTHOUGH THE COMPLAINED DEVICE WAS NOT RETURNED, THE BMR WAS REVIEWED AND NO DISCREPANCIES WERE NOTED. THE TESTS OF THE RETAIN SAMPLE PASSED THE DEFINED SPECIFICATIONS. BASED ON THE INVESTIGATION THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE: THE USER MIXED THE CEMENT FOR 4 MINUTES INSTEAD FOR 4.5 MINUTES, SO THE DEVICE COULD NOT SET UP. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED ISSUES WERE NOT FOUND IN THE INVESTIGATION.

    Description of Event or Problem · 1

    SURGEON USING HYDROSET TO CLOSE CRANIOTOMY AND AFTER 4 MINUTES THE PRODUCT WAS RUNNY AND DID NOT SET UP. ANOTHER PRODUCT USED TO COMPLETE THE SURGERY. NO DELAY OR MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5CC HYDROSET INJECTABLE CEMENT IMPLANT GXP STRYKER ORTHOPAEDICS LIMERICK NA MB5SHIC01150

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK