BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OP-1 IMPLANT (OSTEOGENIC PROTEIN 1)

    MDR report key: 1082286 · Received July 25, 2008

    Report

    Report Number
    1224732-2008-00026
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    September 11, 2007
    Report Date
    July 25, 2008
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 01-JUL-2008, STRYKER BIOTECH RECEIVED A REPORT OF A HUMERAL NON UNION IN A PT (AGE, SEX UNSPECIFIED) WHO RECEIVED ONE UNIT OF OP-1 IMPLANT IN APPROX FIVE MONTHS BEFORE, FOLLOWING A HUMERAL FRACTURE WHICH OCCURRED IN 2007. THE FRACTURE WAS INITIALLY TREATED WITH AN INTERMEDULLARY (IM) ROD. HOWEVER, THE PHYSICIAN REPORTED THAT ONE SECTION FAILED TO HEAL, AND THE PT SUBSEQUENTLY DEVELOPED RADIAL NERVE PALSY. IN THE MONTH OF IMPLANT, THE PT RECEIVED OP-1 IMPLANT FOR THE NON UNION. ON ORIGINAL DATE, THE PHYSICIAN REPORTED THAT THE NON UNION STILL PROGRESSED AND CONTACTED STRYKER BIOTECH TO INQUIRE AS TO THE SAFETY OF ADMINISTERING A SECOND DOSE OF OP-1 IMPLANT. THE PHYSICIAN WAS CAUTIONED BY THE STRYKER BIOTECH MEDICAL DIRECTOR THAT REPEAT DOSING IS CONSIDERED OFF LABEL, BUT WAS ALSO INFORMED THAT PREVIOUS STUDIES SHOWED NO EVIDENCE OF AN INCREASE IN ADVERSE EVENTS ASSOCIATED WITH REPEAT DOSING. THE PHYSICIAN WAS ASKED BY THE STRYKER BIOTECH MEDICAL DIRECTOR TO KEEP STRYKER BIOTECH PHARMACOVIGILANCE APPRISED OF ANY DEVELOPMENTS REGARDING THIS CASE. ADDITIONAL INFO RECEIVED ON 11-JUL-2008 INDICATED THAT THE PT WAS REOPERATED UPON ON THE DAY AFTER THE ORIGINAL DATE. THE OP-1 IMPLANT WAS MIXED WITH STERILE SALINE, HEMOSTASIS WAS ACHIEVED AT THE HUMERAL SITE, AND THE OP-1 IMPLANT WAS APPLIED. FOLLOWING THE APPLICATION, THE SURROUNDING TISSUES WERE CLOSED. NO COMPLICATIONS WERE REPORTED BY THE SURGEON. CURRENTLY, THE PT IS UNABLE TO FLEX DIGITS IV, V (METACARPOPHALANGEAL JOINT) AND HAS REFLEX SYMPATHETIC DYSTROPHY (PATIENT CANNOT WORK). THE PHYSICIAN DOES NOT SUSPECT THAT THE EVENTS WERE RELATED TO THE PRODUCTS USED. 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention