BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALSTRUX (TRICALCIUM PHOSPHATE)

    MDR report key: 1414433 · Received July 13, 2009

    Report

    Report Number
    1224732-2009-00043
    Event Type
    Injury
    Date Received
    July 13, 2009
    Report Date
    July 1, 2009
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL CATALOG NUMBER: 40015, LOT NUMBER: TU07017.

    Description of Event or Problem · 1

    ON 04/21/2009, STRYKER BIOTECH RECEIVED A REPORT THAT A FEMALE PATIENT WHO RECEIVED AN UNKNOWN OP-1 CONTAINING PRODUCT IN 2007, AS PART OF A REVISION PROCEDURE TO TREAT FLATBACK SYNDROME DEVELOPED A POSTOPERATIVE INFECTION IN AN UNSPECIFIED LOCATION. THE PHYSICIAN REPORTED THAT THE INFECTION WAS SERIOUS, REQUIRING HOSPITALIZATION, AND THAT A 'SURGICAL EXPLORATION' WAS PERFORMED. HE ALSO STATED THAT WHILE HE BELIEVED THE EVENTS TO BE SERIOUS, HE DID NOT BELIEVE THEY WERE RELATED TO THE USE OF THE PRODUCT OF INTEREST. THE PHYSICIAN REPORTED THAT THE PATIENT RECOVERED FROM THE EVENTS. THE PATIENT, WHO HAS BEEN DIAGNOSED WITH DIABETES MELLITUS, HAS A MEDICAL HISTORY, WHICH INCLUDED OSTEOMYELITIS AND AN EPIDURAL ABSCESS. ADDITIONAL INFORMATION WILL BE REQUESTED. ON 07/01/2009: ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE REPORTER WERE MADE ON 05/08/2009, 05/21/2009 AND 06/08/2009, BUT NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. INVOICE DOCUMENTATION SUBMITTED BY THE HOSPITAL TO STRYKER BIOTECH INDICATED THAT A PATIENT WITH THE SAME INITIALS, GENDER, AND DATE OF PROCEDURE RECEIVED THE FOLLOWING PRODUCTS: 7 UNITS OF OP-1 PUTTY, CATALOG NUMBER 30050; 1 UNIT CALSTRUX, CATALOG NUMBER 40010, AND 2 UNITS CALSTRUX, CATALOG NUMBER 40015. THIS MDR REPORT REFLECTS THE CALSTRUX DEVICE USAGE. SEE MDR 1224732-2009-00033, WHICH CAPTURES THE OP-1 PUTTY DEVICE USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CALSTRUX (TRICALCIUM PHOSPHATE) IMPLANT MPY STRYKER BIOTECH NA TU07018

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R