BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOBLAST

    MDR report key: 3381578 · Received September 27, 2013

    Report

    Report Number
    MW5032077
    Event Type
    Injury
    Date Received
    September 27, 2013
    Date of Event
    July 23, 2003
    Report Date
    September 26, 2013
    Manufacturer
    INTEGRA LIFE SCIENCES
    Product Code
    MBP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    (B)(6) 2003, SURGEON IMPLANTED UNAPPROVED BIOLOGIC ORTHOBLAST 11 IN COMBINATION WITH HEALOS, INVERTEBRAL AR SPACER AND BIOMET EBI IMPLANTABLE BONE STIMULATOR. THE ORTHOBLAST DEVICE DID NOT HAVE FDA CLEARANCE AT TIME OF PROCEDURE [510 (K) K050642 ((B)(6) 2005)]; SURGEON (S) CONDUCTED UNAUTHORIZED CLINICAL TRIALS USING ABOVE COMBINATION OF DEVICES WITHOUT OBTAINING IDE, IRB OR CONSENT FROM PT. PT DEVELOPED SEVERE POST-OPERATIVE COMPLICATIONS, INCLUDING BUT NOT LIMITED TO, ADVERSE SWELLING, INFECTION, RADICULOPATHY AND MYELOPATHY NECESSITATING IMPLANTATION OF A TENS PAIN UNIT, ESOPHAGEAL REMEDIAL SURGERY, AND INTRATHECAL PAIN PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489792 ORTHOBLAST ORTHOBLAST MBP INTEGRA LIFE SCIENCES

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R| S