BEUDAMED
    FDA Adverse Event Other Summary report: N

    INFUSE RHBMP-2/ACS

    MDR report key: 1066441 · Received June 26, 2008

    Report

    Report Number
    MW5007448
    Event Type
    Other
    Date Received
    June 26, 2008
    Date of Event
    September 4, 2007
    Report Date
    June 26, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    NEK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN '07, THE PATIENT UNDERWENT A RIGHT MAXILLARY SINUS BONE GRAFT IN PREPARATION FOR A DENTAL IMPLANT. THE GRAFTING MATERIAL USED WAS INFUSE RHBMP-2/ACS RECOMBINANT BONE MORPHOGENIC PROTEIN. AT APPROX 11 DAYS LATER, THE PATIENT BEGAN TO COMPLAIN FO RIGHT SINUS PAIN A ND CONGESTION. COURSES OF ANTIBIOTIC AND STEROID TREATMENT FOLLOWED. OVER THE COURSE OF THE REQUIRED HEALING TIME FOR THIS GRAFT, THE PATIENT'S SYMPTOMS IMPROVED, WITH RAPID RESOLUTION OF PAIN, BUT CONTINUED COMPLAINT OF CONGESTION. SHE WAS ULTIMATELY TREATED FOR CHRONIC RIGHT MAXILLARY SINUSITIS BY UNDERGOING SINUS ENDOSCOPY, MIDDLE MEATAL ANTROSTOMY, AND RIGHT PARTIAL MIDDLE TURBINECTOMY. DOSE OR AMOUNT: 4.2 MG IN 5 ML SALINE. ROUTE: OTHER. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: MAXILLARY SINUS BONE GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE RHBMP-2/ACS 4.2MG/5ML NEK MEDTRONIC * M110609AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other