BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1132263 · Received August 12, 2008

    Report

    Report Number
    1030489-2008-00432
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    September 4, 2007
    Report Date
    July 17, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P050053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT DID NOT REVEAL ANY NON-CONFORMANCES TO SPEC WHICH MIGHT CONTRIBUTE TO THE REPORTED EVENT. NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. PER THE PHYSICIAN, THIS EVENT WAS MOST LIKELY RELATED TO THE ANATOMICAL FEATURES OF THE PT AND WAS NOT LIKELY RELATED TO THE INFUSE BONE GRAFT. DURING THE REVISION PROCEDURE, THE GRAFT WAS EXAMINED VIA ENDOSCOPY AND WAS FOUND TO HAVE NO CLINICAL FAILURE. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA VOLUNTARY MEDWATCH THAT A PT UNDERWENT A RIGHT MAXILLARY SINUS BONE GRAFT IN PREPARATION FOR A DENTAL IMPLANT. THE GRAFTING MATERIAL INCLUDED RHBMP-2/ACS. APPROX 11 DAYS POST-OP, THE PT BEGAN TO COMPLAIN OF RIGHT SINUS PAIN AND CONGESTION. COURSES OF ANTIBIOTIC AND STEROID THERAPY WERE ADMINISTERED. OVER THE COURSE OF THE REQUIRED HEALING TIME FOR THIS GRAFT, THE PT'S SYMPTOMS IMPROVED, WITH RAPID RESOLUTION OF THE PAIN, BUT THE PT CONTINUED TO COMPLAIN OF CONGESTION. THE PT WAS ULTIMATELY FOUND TO HAVE RIGHT MAXILLARY SINUSITIS AFTER UNDERGOING SINUS ENDOSCOPY, MIDDLE MEATAL ANTROSTOMY, AND RIGHT PARTIAL MIDDLE TURBINECTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSE BONE GRAFT INFUSE BONE GRAFT NEK MEDTRONIC SOFAMOR DANEK USA, INC. NA M110609AAE

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention