BEUDAMED
    FDA Adverse Event Summary report: N

    OP-1 IMPLANT (OSTEOGENIC PROTEIN 1)

    MDR report key: 2212473 · Received February 14, 2007

    Report

    Report Number
    1224732-2007-00005
    Date Received
    February 14, 2007
    Report Date
    February 6, 2007
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MQV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: CALSTRUX (TRICALCIUM PHOSPHATE). TYPE OF DEVICE: IMPLANT. MANUFACTURER NAME, CITY AND STATE: STRYKER BIOTECH, (B)(4). MODEL # NA, CATALOG# 40010, SERIAL# NA, LOT# TUAN006, EXPIRATION DATE: UNK. HEALTH PROFESSIONAL. (B)(6). ADDITIONAL LOT# (OP-1 IMPLANT): FC0601008.

    Description of Event or Problem · 1

    A (B)(6) FEMALE WHO RECEIVED 2 UNITS OF OP-1 IMPLANT COMBINED WITH 10 CC'S OF CALSTRUX ON (B)(6) 2006, FOR A DISTAL TIBIA NONUNION, EXPERIENCED DRAINAGE OF CALSTRUX FROM THE WOUND. THE WOUND HAS NOT HEALED. BOTH EVENTS CONTINUE. TREATMENT INCLUDED IRRIGATION ON SEVERAL OCCASIONS. NO OTHER SYMPTOMS ARE BEING EXPERIENCED AND THE BONE HAS HEALED WITH GOOD FUSION. THE SURGEON SUSPECTS THE EVENTS WERE RELATED TO THE USE OF THE PRODUCTS. THE INITIAL FRACTURE OCCURRED DURING A MOTOR VEHICLE ACCIDENT ON (B)(6) 2005 AND REQUIRED AN UNSPECIFIED SURGERY. DESPITE THE CURRENT NONSERIOUS NATURE OF THIS CASE, IT WAS DECIDED TO SUBMIT IT IN AN EXPEDITED MANNER. ADDITIONAL INFO WILL BE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OP-1 IMPLANT (OSTEOGENIC PROTEIN 1) IMPLANT MQV STRYKER BIOTECH NA FC0606009

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR