BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3201193 · Received July 2, 2013

    Report

    Report Number
    1030489-2013-02870
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    February 7, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P050053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE CITATION: DESAI ET AL. USE OF RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN 2 FOR MANDIBLE RECONSTRUCTION. (B)(4). MEAN AGE, (B)(6). PATIENTS: 3 MALES, 3 FEMALES. IMPLANTED DATE: BETWEEN (B)(6) 2004 AND (B)(6) 2009. (B)(4). 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. PRODUCTS FROM MULTIPLE MANUFACTURERS WERE IMPLANTED DURING THE PROCEDURE. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE PUBLICATION THAT A RETROSPECTIVE REVIEW WAS PERFORMED OF PATIENTS WHO HAD UNDERGONE REPAIR OF A MANDIBLE DEFECT USING RHBMP-2 WITH BETA-TRICALCIUM PHOSPHATE MATRIX OR A CADAVERIC BONE GRAFT. 6 PATIENTS UNDERWENT RECONSTRUCTION WITH THE USE OF RHBMP-2 FOR SEGMENTAL OR NEAR-COMPLETE RIM MANDIBULECTOMY DEFECTS. THE DEFECT LENGTHS RANGED FROM 5 TO 12 CM. THE NEAR-COMPLETE RIM MANDIBULECTOMY DEFECTS ALL HAD A REMAINING MANDIBLE HEIGHT OF LESS THAN 8 MM. FIVE PATIENTS HAD BENIGN NEOPLASMS, AND 1 PATIENT HAD CHRONIC MALUNION SECONDARY TO TRAUMA. ALL 6 PATIENTS EXPERIENCED MODERATE FACIAL SWELLING AFTER SURGERY THAT RESOLVED WITHIN 2 WEEKS. NO PATIENT REQUIRED ANY AIRWAY INTERVENTION FOR HIS OR HER POSTOPERATIVE SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301531 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Other