BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OP-1 IMPLANT (EPTOTERMIN ALFA)

    MDR report key: 1940442 · Received December 20, 2010

    Report

    Report Number
    1224732-2010-00027
    Event Type
    Injury
    Date Received
    December 20, 2010
    Report Date
    December 2, 2010
    Manufacturer
    STRYKER BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2010, STRYKER PVG LEARNED OF AN ADVERSE EVENT IN THE LITERATURE: BIRKE ET AL, 'PRELIMINARY EXPERIENCE WITH THE COMBINED USE OF RECOMBINANT BONE MORPHOGENETIC PROTEIN AND BISPHOSPHONATES IN THE TREATMENT OF CONGENITAL PSEUDARTHROSIS OF THE TIBIA', PUBLISHED IN J CHILD ORTHOP (2010) 4, 507-517. IN THE ARTICLE, THE AUTHORS REPORT THAT A (B)(6) MALE PT WITH NEUROFIBROMATOSIS TYPE 1 (NF1) EXPERIENCED TREATMENT FAILURE AFTER RECEIVING OP-1 FOR PSEUDARTHROSIS OF THE TIBIA. ADDITIONAL INFO WAS REQUESTED FROM THE AUTHORS ON 12/08/2010 AND 12/15/2010. ON 12/16/2010, THE CORRESPONDING AUTHOR NOTIFIED STRYKER PVG VIA EMAIL THAT HE WOULD BE UNABLE TO PROVIDE ADDITIONAL INFO REGARDING THE PTS IN THE ARTICLE. NO FURTHER INFO IS EXPECTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention