BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 3781412 · Received April 30, 2014

    Report

    Report Number
    1030489-2014-02359
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 2, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: CHAN ET AL. WOUND COMPLICATIONS ASSOCIATED WITH BMP-2 IN ORTHOPAEDIC TRAUMA SURGERY. JOURNAL OF ORTHOPAEDIC TRAUMA. 2014. DOI: 10.1097/BOT.0000000000000117. AVERAGE AGE 52 YEARS. RANGE 16 - 90 YEARS. IMPLANT DATE: 2002-2009. (B)(6). (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 THAT A RETROSPECTIVE CHART AND X-RAY REVIEW WAS PERFORMED ON CASES PERFORMED BETWEEN 2002 AND 2009 AT A SINGLE TRAUMA CENTER IN WHICH RHBMP-2 WAS USED IN ACUTE TRAUMA OR POST-TRAUMATIC RECONSTRUCTION. THESE CASES WERE THEN COMPARED TO A MATCHED COHORT WITHOUT THE USE OF BMP-2 (MATCHED FOR AGE, TYPE OF CASE, ANATOMIC SITE, AND OPEN INJURY) FOR STATISTICAL ANALYSIS. GROUP ONE WAS COMPRISED OF A TOTAL OF 193 PATIENTS WHOSE TREATMENT INCLUDED RHBMP-2 (155 RECONSTRUCTIVE AND 38 ACUTE OPEN FRACTURES). GROUP TWO WAS COMPRISED OF 181 PATIENTS TREATED WITHOUT THE USE OF RHBMP-2 (145 RECONSTRUCTIVE AND 36 ACUTE OPEN FRACTURES). FOR THE ACUTE TRAUMA CASES, ALL WERE OPEN FRACTURES WHERE RHBMP-2 WAS APPLIED AFTER THE FINAL DEBRIDEMENT AND IMMEDIATELY PRIOR TO DEFINITIVE WOUND CLOSURE DURING THE INITIAL HOSPITALIZATION. RECONSTRUCTIVE CASES WERE COMPRISED EITHER OF DIAPHYSEAL NONUNIONS OR PRIMARY OR REVISION POST-TRAUMATIC FOOT <(>&<)> ANKLE FUSIONS WHERE RHBMP-2 WAS APPLIED IN AN OFF-LABEL FASHION TO ENHANCE NONUNION REPAIR OR ARTHRODESIS, RESPECTIVELY. SEVENTEEN PATIENTS IN THE BMP GROUP REQUIRED PROLONGED ANTIBIOTIC USE POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260831 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 00052 YR Required Intervention