BEUDAMED
    FDA Adverse Event Summary report: N

    CALSTRUX

    MDR report key: 1004121 · Received February 22, 2008

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    Report

    Report Number
    1224732-2008-00008
    Date Received
    February 22, 2008
    Date of Event
    January 17, 2008
    Report Date
    February 12, 2008
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A SALES REPRESENTATIVE REPORTED THAT A MALE PATIENT (R.H.) HAD A SINGLE LEVEL PLF DONE IN 2008 AND DEVELOPED A GRAM POSITIVE INFECTION 10 DAYS AFTER RECEIVING 1 UNIT OF OP-1 WITH 5 CC OF CALSTRUX AS PART OF A SINGLE LEVEL PLF. NO MIGRATION WAS NOTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION WAS RECEIVED ABOUT 2 MONTHS LATER. A WOUND CULTURE WAS PERFORMED AND REVEALED THE INFECTION TO BE GRAM POSITIVE STAPHYLOCOCCUS AUREUS. THE DATE OF ONSET WAS 10 DAYS POST PROCEDURE. THE PHYSICIAN SUSPECTS THE EVENT IS RELATED TO OP-1 PUTTY. THE PATIENT WAS RETURNED TO THE OR APPROX 2 WEEKS AFTER THE PROCEDURE FOR INCISION AND DRAINAGE PROCEDURE (I & D) AND PLACED ON IV ANTIBIOTICS (NOS) FOR 6-12 WEEKS. THE INFECTION HAS NOT RESOLVED AS AT ABOUT 10 DAYS AFTER THE DRAINAGE. ADDITIONAL INFORMATION WAS RECEIVED 2 WEEKS AFTER THE DRAINAGE. THE INFECTION BECAME SYSTEMIC AND THE PATIENT WAS PLACED ON THE FOLLOWING MEDICATIONS: CEFTAZIDIME 1 G. NAFCILLIN, 2 G IV. VANCOMYCIN, 1 G. VANCOMYCIN, 1.5 G. ORAL RIFAMPIN 150 MG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALSTRUX IMPLANT MPY NA

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R