BEUDAMED
    FDA Adverse Event Other Summary report: N

    OSIGRAFT

    MDR report key: 3840775 · Received May 12, 2014

    Report

    Report Number
    1224732-2014-00033
    Event Type
    Other
    Date Received
    May 12, 2014
    Report Date
    April 15, 2014
    Manufacturer
    OLLYMPUS BIOTECH
    Product Code
    MPY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2014 OLYMPUS BIOTECH RECEIVED A REPORT THAT FIVE PATIENTS WHO RECEIVED OSIGRAFT AS PART OF AN UNSPECIFIED PROCEDURE SUBSEQUENTLY EXPERIENCED HETEROTOPIC OSSIFICATION. ONE OF THE PATIENTS EXPERIENCED HETEROTOPIC OSSIFICATION IN THE UPPER LIMB AND ANOTHER EXPERIENCED THE HETEROTOPIC OSSIFICATION IN THE FEMUR. THE FEEDBACK WAS PRESENTED AT AN ORTHOPAEDIC CONFERENCE HELD IN THE (B)(6). NO ADDITIONAL INFORMATION WAS PROVIDED WITH THE INITIAL REPORT. THE OLYMPUS BIOTECH MEDICAL REVIEWER ASSESSED THE EVENTS AS OF UNKNOWN SERIOUSNESS AND POSSIBLY RELATED TO THE OSIGRAFT. THIS AGGREGATE CASE HAS BEEN CREATED PENDING RECEIPT OF ADDITIONAL INFORMATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283284 OSIGRAFT NONE MPY OLLYMPUS BIOTECH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK