BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4793308 · Received May 22, 2015

    Report

    Report Number
    1030489-2015-01035
    Event Type
    Injury
    Date Received
    May 22, 2015
    Date of Event
    April 1, 2015
    Report Date
    April 23, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: POURTAHERI ET AL. ULTRA-LOW-DOSE RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2 FOR 3-LEVEL ANTERIOR CERVICAL DISKECTOMY AND FUSION. ORTHOPEDICS. 2015 APR 1;38(4):241-245. (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 IN A PUBLICATION THAT THE AUTHORS RETROSPECTIVELY REVIEWED THE CLINICAL AND RADIOGRAPHIC OUTCOMES OF ALL 3-LEVEL ACDFS WITH 0.26 TO 0.35 MG/LEVEL OF RHBMP-2 PERFORMED BETWEEN 2008 AND 2011. THE STUDY (B)(6) INCLUDED 37 CONSECUTIVE PATIENTS. NO PATIENT WAS LOST TO FOLLOW-UP. THE PRIMARY INDICATION FOR SURGERY WAS SYMPTOMATIC SPONDYLOTIC MYELOPATHY. ALL PATIENTS WERE GIVEN A PREOPERATIVE INTRAVENOUS (IV) DOSE OF METHYLPREDNISOLONE TO DECREASE POSTOPERATIVE DYSPHAGIA AND AIRWAY COMPLICATIONS. ALL ANTERIOR FUSIONS WERE PERFORMED THROUGH A SMITH-ROBINSON APPROACH. RECOMBINANT HUMAN BMP-2 WAS PREPARED AT A CONCENTRATION OF 0.26 TO 0.35 MG/LEVEL (BETWEEN ONE-EIGHTH AND ONE-SIXTH OF AN EXTRA-SMALL SPONGE 1.4 ML AT 1.5 MG/ML) WITH CORTICOCANCELLOUS ALLOGRAFT (VG2 ALLOGRAFT; DEPUY SYNTHES SPINE). FOUR MILLIMETER DRILL HOLES WERE MADE IN THE TOP AND BOTTOM OF THE ALLOGRAFT SPACERS, AND THE RHBMP-2 WAS PLACED IN THESE HOLES. A FIBRIN SEALANT (TISSEEL) WAS PLACED ANTERIORLY OVER THE GRAFTS FOR CONTAINMENT OF THE RHBMP-2 FROM THE ANTERIOR STRUCTURES. FIVE (14%) PATIENTS HAD A SINGLE CERVICAL CORPECTOMY ADJACENT TO AN ACDF AT THE INDEX SURGERY. IN ALL CASES, AN EAGLE ANTERIOR CERVICAL LOCKING PLATE (DEPUY SYNTHES SPINE) WAS USED. CERVICAL DRAINS WERE USED IN ALL CASES. POSTOPERATIVELY, ALL PATIENTS WERE PLACED ON AN IV TAPERED DOSE OF METHYLPREDNISOLONE WHILE IN THE HOSPITAL AND CONVERTED TO AN ORAL TAPERED DOSE AT DISCHARGE. PATIENTS WERE DISCHARGED ONCE LIQUIDS WERE TOLERATED. A HARD COLLAR WAS WORN FOR THE FIRST 2 WEEKS, FOLLOWED BY A SOFT COLLAR FOR 2 WEEKS. PHYSICAL THERAPY WAS INITIATED APPROXIMATELY 6 WEEKS POSTOPERATIVELY AND INCLUDED BILATERAL SHOULDER GIRDLE MODALITIES ADDRESSING PAIN AND STIFFNESS. THE AUTHORS OBSERVED NO AIRWAY OR CERVICAL SWELLING COMPLICATIONS. MEAN SWELLING ANTERIOR TO THE C2 AND C3 VERTEBRAL BODIES 2 WEEKS POSTOPERATIVELY WAS 4.8 AND 9.6 MM, RESPECTIVELY. THERE WERE 4 CASES OF SUBSIDENCE. MEAN LORDOSIS IMPROVED FROM 3.8° PREOPERATIVELY TO 16.5° POSTOPERATIVELY (P=.0001). NONE OF THE CASES OF SUBSIDENCE WERE SYMPTOMATIC. NO INCIDENCE OF GRAFT MIGRATION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335233 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 00055 YR Required Intervention