BEUDAMED
    FDA Adverse Event Other Summary report: N

    OP-1 IMPLANT (OSTEOGENIC PROTEIN 1)

    MDR report key: 1558641 · Received December 9, 2009

    Report

    Report Number
    1224732-2009-00057
    Event Type
    Other
    Date Received
    December 9, 2009
    Report Date
    December 1, 2009
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ON 01-DEC-09, STRYKER BIOTECH REVIEWED A LITERATURE ARTICLE (ENHANCEMENT OF DIFFICULT NONUNION IN CHILDREN WITH OSTEOGENIC PROTEIN-1 (OP-1) - EARLY EXPERIENCE. BRUNO DOHIN MD, NOEMI DAHAN-OLIEL MSC, FRANCOIS FASSIER MD, REGGIE HAMDY MD. (CLIN ORTHOP RELAT RES. DOI 10.1007/S11999-009-0967-7) THAT DESCRIBES A RETROSPECTIVE CHART REVIEW OF 19 PEDIATRIC PTS IN (B)(6) WHO RECEIVED OP-1 IMPLANT BETWEEN 1999 AND 2007. THE ARTICLE INDICATES THAT SOME PTS EXPERIENCED NON-UNION AND SUPERFICIAL PIN SITE INFECTIONS. FURTHER INFO HAS BEEN REQUESTED FROM THE AUTHORS REGARDING DETAILS OF THESE PTS AND ADVERSE EVENTS EXPERIENCED. THIS INITIAL MDR IS BEING SUBMITTED AS AN AGGREGATE REPORT UNTIL FURTHER INFO IS REC'D.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other