BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOBLAST-II PASTE

    MDR report key: 4817734 · Received June 2, 2015

    Report

    Report Number
    2090010-2015-00007
    Event Type
    Injury
    Date Received
    June 2, 2015
    Report Date
    May 8, 2015
    Manufacturer
    ISOTIS ORTHOBIOLOGICS, INC
    Product Code
    MBP
    PMA / PMN Number
    K050642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WILL NOT BE RETURNED SINCE IT REMAINS IMPLANTED. BASED ON REPORTED INFORMATION, INTEGRA HAS INITIATED AN INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INFORMATION OMITTED FROM INITIAL REPORT IN ERROR. THE PRODUCT WAS NOT EXPLANTED. INTEGRA HAS COMPLETED THE INTERNAL INVESTIGATION ON 06/11/2015. THE ADDITIONAL INVESTIGATION ACTIVITIES INCLUDED: METHODS: REVIEW OF DEVICE HISTORY RECORDS; REVIEW OF COMPLAINT HISTORY. RESULTS: ORTHOBLAST II PASTE PRODUCT WAS MANUFACTURED UNDER LOT NUMBER 130608. THE COMPLETE DEVICE HISTORY RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED. THE PRODUCT WAS MANUFACTURED AND RELEASED IN ACCORDANCE WITH PRODUCT SPECIFICATIONS. THE PRODUCT IS TERMINALLY STERILIZED ACCORDING TO REQUIRED SPECIFICATIONS. WHEN USED PRIOR TO THE EXPIRATION DATE, THE PROBABILITY OF HAVING CONTAMINATION IS ONE IN ONE-MILLION. THE COMPLAINT DATABASE WAS REVIEWED FOR THE LAST TWO YEARS AND THERE WERE NO RELATED INCIDENTS FOR THIS PRODUCT OR ISSUE. CONCLUSION: THE PRODUCT WAS USED "OFF LABEL".

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON IMPLANTED A "PASTE" PRODUCT, HOWEVER, AFTERWARD HE NOTICED THAT THE PRODUCT WAS EXPIRED BY 2 DAYS. NO PATIENT IMPACT WAS INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355661 ORTHOBLAST-II PASTE NONE MBP ISOTIS ORTHOBIOLOGICS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other