BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CALSTRUX (TRICALCIUM PHOSPHATE)

    MDR report key: 1414431 · Received July 13, 2009

    Report

    Report Number
    1224732-2009-00041
    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: 40010. LOT NUMBER: TU06030. EXPIRATION DATE: 02/29/2008.

    Description of Event or Problem · 1

    ON 04/21/2009, STRYKER BIOTECH RECEIVED A REPORT OF WOUND INFECTION AND WOUND DEHISCENCE IN A MALE PATIENT WHO RECEIVED OP-1 PUTTY IN 2007, AS PART OF THORACIC DECOMPRESSION AND FUSION FOR MYELOPATHY. THE PHYSICIAN REPORTED THAT THE PATIENT HAD 'SIGNIFICANT MORBIDITY' INCLUDING OSTEOPOROSIS AND DIABETES MELLITUS AND HAD UNDERGONE A PREVIOUS ILIAC CREST BONE GRAFT FOR A CERVICAL ANTERIOR/POSTERIOR PROCEDURE ON AN UNSPECIFIED DATE. THE PATIENT RECOVERED FROM THESE EVENTS. THE PHYSICIAN REPORTED THAT THE INFECTION AND WOUND DEHISCENCE WERE SERIOUS, REQUIRING HOSPITALIZATION AND THAT 'SURGICAL EXPLORATION' (UNSPECIFIED) WAS PERFORMED. THE PHYSICIAN STATED THAT HE DID NOT BELIEVE THAT THE EVENTS WERE RELATED TO THE USE OF THE OP-1 PUTTY. ADDITIONAL INFORMATION WILL BE REQUESTED. ON 07/01/2009: THE INITIAL INFORMATION PROVIDED BY THE REPORTER DID NOT IDENTIFY THE CATALOG NUMBER OF THE DEVICE, BUT STATED THAT THE PATIENT RECEIVED OP-1 PUTTY. 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: 4 UNITS OF OP-1 PUTTY, CATALOG NUMBER 30050. IN ADDITION, INVOICE DOCUMENTATION SUBMITTED BY THE HOSPITAL TO STRYKER BIOTECH ALSO INDICATES THAT THIS PATIENT RECEIVED 1 UNIT OF CALSTRUX, CATALOG NUMBER 40005, AND ONE UNIT OF CALSTRUX, CATALOG NUMBER 40010. THIS MDR REPORT REFLECTS THE CALSTRUX DEVICE USAGE. SEE MDR 1224732-2009-00025, 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 TU06029

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R