BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOPLEX W/VERTAPLEX HV

    MDR report key: 2070976 · Received April 19, 2011

    Report

    Report Number
    2648666-2011-00113
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    March 23, 2011
    Manufacturer
    STRYKER INSTRUMENTS PUERTO RICO
    Product Code
    LOD
    PMA / PMN Number
    K091606
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS BEING TREATED FOR MULTIPLE ISSUES AND WAS AN "INPATIENT" STATUS BEFORE THE ORIGINAL PROCEDURE TOOK PLACE. THE CEMENT MIXING DEVICE OPERATED AS INTENDED DURING THE PROCEDURE. THE INSTRUCTIONS FOR USE INCLUDES THE WARNING: "THE MEDICAL PERSONNEL ALWAYS NEED TO MONITOR THE AMOUNT AND PLACEMENT OF INJECTED CEMENT WITH EXTREME CARE. VARIATION IN INCREMENTAL AND TOTAL CEMENT DELIVERY MAY OCCUR BECAUSE, CEMENT IS A COMPRESSIBLE MATERIAL. A BUILD UP OF PRESSURE MAY CAUSE CEMENT TO SUDDENLY FLOW AND OVERFILL THE FRACTURE."

    Description of Event or Problem · 1

    AFTER A SUCCESSFULLY COMPLETED VCF PROCEDURE, A RADIOLOGY SCAN REVEALED THAT SOME CEMENT HAD LEAKED INTO THE PT'S LUNGS. THE SURGEON DETERMINED THAT NO ADDITIONAL TREATMENT WAS REQUIRED. IT IS FURTHER REPORTED THAT THE PT IS DOING WELL POST OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOPLEX W/VERTAPLEX HV LOD STRYKER INSTRUMENTS PUERTO RICO VHR015

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other