BEUDAMED
    FDA Adverse Event Other Summary report: N

    OP-1 IMPLANT (OSTEOGENIC PROTEIN 1)

    MDR report key: 1943823 · Received December 22, 2010

    Report

    Report Number
    1224732-2010-00030
    Event Type
    Other
    Date Received
    December 22, 2010
    Report Date
    December 9, 2010
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    STRYKER (B)(4) RECEIVED A REPORT FROM A PHYSICIAN WHO USED TCP PUTTY (CALSTRUX) IN CONJUNCTION WITH A LIZARD EX-FIX IN (B)(6) 2005, TO TREAT A PT'S LEFT TIBIA. NO ADDITIONAL INFO WAS PROVIDED. ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE RPTR WERE MADE ON (B)(6) 2010, (B)(6) 2010 AND (B)(6) 2010, BUT NO ADDITIONAL INFO WAS RECEIVED. ON (B)(6) 2010: STRYKER BIOTECH REVIEWED INVOICE DOCUMENTATION FOR A PT (B)(6) TREATED BY THE RPTR AT (B)(6). THIS PT RECEIVED ONE UNIT OF OP-1 IMPLANT, CATALOG NUMBER 10025 AND ONE UNIT OF TCP PUTTY (CALSTRUX), CATALOG NUMBER 40015 ON (B)(6) 2005, AS PART OF AN UNK LEFT TIBIAL PROCEDURE. IT IS NOT KNOWN IF THIS IS THE SAME PT WHO WAS REPORTED TO HAVE RECEIVED TCP PUTTY IN CONJUNCTION WITH A LIZARD EX-FIX IN (B)(6) 2005. THIS MDR IS BEING CREATED TO CAPTURE THE POTENTIAL THAT A PT RECEIVED BOTH OP-1 IMPLANT AND THE TCP PUTTY (CALSTRUX) AND THE PHYSICIAN HAD A COMPLAINT ASSOCIATED WITH THE USE OF THE PRODUCTS. NO ADDITIONAL INFO IS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OP-1 IMPLANT (OSTEOGENIC PROTEIN 1) IMPLANT MPY STRYKER BIOTECH FD0412005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other