BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1286535 · Received January 8, 2009

    Report

    Report Number
    1030489-2009-00021
    Event Type
    Injury
    Date Received
    January 8, 2009
    Report Date
    December 9, 2008
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC.
    Product Code
    NEK
    PMA / PMN Number
    P000054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY AXELRAD ET AL. IN AN ARTICLE ENTITLED "HETEROTOPIC OSSIFICATION AFTER THE USE OF COMMERCIALLY AVAILABLE RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEINS IN FOUR PATIENTS" IN THE JOURNAL OF BONE AND JOINT SURGERY (BR)200890-B:1617-22 THAT A PATIENT DEVELOPED HETEROTOPIC BONE GROWTH AFTER TREATMENT WITH RHBMP-2/ACS. THE PATIENT HAD FALLEN 25 FEET AND SUSTAINED A GRADE-II OPEN SUPRACONDYLAR FRACTURE OF THE LEFT HUMERUS. ON THE 22ND DAY AFTER THE INJURY, THE PATIENT UNDERWENT A FIXATION PROCEDURE. THE ELBOW WAS APPROACHED POSTERIORLY FOR FIXATION OF THE MEDIAL AND LATERAL COLUMNS. AFTER REDUCTION, A GAP, WHICH REMAINED MEDIALLY WAS FILLED WITH FRESH AUTOGRAFT CONSISTING OF FRACTURE CALLUS AND NEW BONE INITIALLY DEBRIDED FROM THE SITE OF THE FRACTURE. THE GRAFT WAS AUGMENTED WITH RHBMP-2/ACS WITH THE SPONGE PLACED ALONG THE ANTEROMEDIAL, ANTEROLATERAL AND DIRECT ANTERIOR BOARDERS OF THE DISTAL HUMERUS. POSTOPERATIVE REHAB INCLUDED SERIAL STATIC SPLINTING WHICH GRADUALLY INCREASED THE DEGREE OF EXTENSION. AT SEVEN WEEKS, RADIOGRAPHS SHOWED ADEQUATE FORMATION OF CALLUS AND MAINTENANCE OF REDUCTION, WITH SOME HETEROTOPIC OSSIFICATION PREDOMINANTLY POSTERIORLY. AT FIVE MONTHS AFTER INJURY, THE PATIENT PRESENTED WITH AN ACUTE DECREASE IN RANGE OF MOVEMENT AND WITH THE ELBOW FIXED AT 90 DEGREES. RADIOGRAPHS SHOWED BRIDGING HETEROTOPIC OSSIFICATION FROM THE OLECRANON TO THE DISTAL HUMERUS WHICH EXTENDED POSTERIORLY INTO THE FASCIAL PLANES. THE PATIENT UNDERWENT EXCISION OF THE HETEROTOPIC BONE WITH CAPSULAR RELEASE AND MANIPULATION UNDER ANAESTHESIA. AT THE MOST RECENT FOLLOW-UP, THE RANGE OF MOVEMENT HAD DECREASED TO 30 DEGREES TO 100 DEGREES. RADIOGRAPHS SHOWED NO RECURRENT HETEROTOPIC OSSIFICATION AND STABLE REDUCTION OF THE ELBOW.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention