BEUDAMED
    FDA Adverse Event Other Summary report: N

    OP-1 IMPLANT (OSTEOGENIC PROTTEIN 1)

    MDR report key: 3911501 · Received May 27, 2014

    Report

    Report Number
    1224732-2014-00039
    Event Type
    Other
    Date Received
    May 27, 2014
    Date of Event
    May 29, 2004
    Report Date
    May 1, 2014
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    ON (B)(6) 2014 OLYMPUS BIOTECH RECEIVED A REPORT OF ADVERSE EVENTS IN A DRAFT MANUSCRIPT ENTITLED "THE TREATMENT OF ATROPHIC, RECALCITRANT LONG-BONE NONUNION WITH HUMAN RECOMBINANT BONE MORPHOGENETIC PROTEIN-7 (RHBMP-7): A RETROSPECTIVE REVIEW" (B)(6) . IN THIS MANUSCRIPT, THE SAFETY AND EFFICACY OF OP-1 IMPLANT IN 95 PATIENT TREATED FOR RECALCITRANT LONG-BONE NONUNION BETWEEN 1997 AND 2012 IN A SINGLE CANADIAN INSTITUTION WAS PRESENTED. THIS REPORT CONCERNS A (B)(6) PATIENT (GENDER UNK, STUDY ID #(B)(6) ) WHO RECEIVED ON UNIT OF OP-1 IMPLANT WITH PLATE FIXATION ON (B)(6) 2004 TO TREAT A HUMERAL NONUNION. ON (B)(6) 2004, THE PATIENT EXPERIENCED A "SURGICAL COMPLICATION" WHICH REQUIRED EVACUATION OF A HEMATOMA AND ADMINISTRATION OF PICC ANTIBIOTICS. AT THE TWO-WEEK POST-OPERATIVE VISIT ON (B)(6) 2004, MILD PAIN, HEMATOMA, AND DRAINAGE WERE REPORTED. AT THE ONE YEAR POST-OPERATIVE VISIT ON (B)(6) 2005, A DEEP INFECTION REQUIRING DEBRIDEMENT WAS REPORTED. BONE UNION WAS NOT ACHIEVED AT THE ONE YEAR POST-OPERATIVE VISIT AND THE PATIENT WAS CONSIDERED A TREATMENT FAILURE. THE OUTCOME OF THE EVENTS WAS UNKNOWN. ON (B)(6) 2006 THE PATIENT HAD HARDWARE REMOVAL, REPAIR, AND ICBG. THE AUTHOR DID NOT PROVIDE AN ASSESSMENT OF SERIOUSNESS AND RELATEDNESS. THE MANUFACTURER'S MEDICAL REVIEWER ASSESSED THESE EVENTS AND POSSIBLY RELATED TO OP-1 IMPLANT AND OF UNKNOWN SERIOUSNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310471 OP-1 IMPLANT (OSTEOGENIC PROTTEIN 1) IMPLANT MPY STRYKER BIOTECH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR