BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 1920027 · Received December 10, 2010

    Report

    Report Number
    1030489-2010-01561
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED IN THIS MEDWATCH WAS REPORTED TO MEDTRONIC BUNDLED WITH ELEVEN OTHER REPORTED ADVERSE EVENTS FROM A SINGLE LOCATION. THERE WAS NO DEFINITIVE EVIDENCE PROVIDED AT THE TIME TO CORRELATE PATIENTS WITH ALL OF THE REPORTED ADVERSE EVENTS. WITH A LACK OF FURTHER INFORMATION, WE FILED AN MDR FOR THIS CASE TO MEET THE 30-DAY DEADLINE, OUT OF AN ABUNDANCE OF CAUTION. ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN CONFIRMED THAT THIS REPORTED ADVERSE EVENT OCCURRED IN A PATIENT THAT WAS REPORTED UNDER A DIFFERENT 3500A FORM. THIS MDR SHOULD NOT HAVE BEEN FILED. PLEASE REFER TO MDRS 1030489-2010-01564, 1030489-2010-01562, 1030489-2010-01560, 1030489-2010-01550, 1030489-2010-01549, 1030489-201 0-01553, AND 1030489-2010-01563 FOR THE INFORMATION PROVIDED BY THIS REPORTER.

    Additional Manufacturer Narrative · 1

    (B)(4) LITERATURE CITATION: MOBASSER, ET AL. MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION AUGMENTED WITH RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN-2. CAGE, PEDICLE SCREWS AND RODS. NO IMPLANT OR THERAPY DATES WERE PROVIDED. PRODUCT REMAINS IMPLANTED. A REVIEW OF THE CERTIFICATES OF ANALYSIS AND PACKING LIST FOR THE INFUSE BONE GRAFT WAS NOT POSSIBLE WITHOUT ADDITIONAL DEVICE INFORMATION. WITHOUT RETURN OF THE DEVICE OR ASSOCIATED RECORDS IT IS NOT POSSIBLE TO ASCERTAIN A CAUSE FOR THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT A RETROSPECTIVE STUDY OF 49 PATIENTS' MEDICAL CHARTS, COMPUTED TOMOGRAPHY (CT) SCANS, AND PATIENT SELF-ASSESSMENT DISABILITY SCORES WAS PERFORMED TO EVALUATE MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION (MIS TLIF) AUGMENTED WITH RH BMP-2. AT LEAST 12 MONTHS PRIOR TO STUDY INITIATION, ALL PATIENTS HAD RECEIVED RHBMP-2 (2.8 ML OR 5.6 ML FOR A SINGLE LEVEL, 8.0 ML FOR TWO LEVELS) AS PART OF THEIR MIS TLIF PROCEDURE. SURGICAL DISTRACTION AND ENDPLATE PREPARATION HAD BEEN CARRIED OUT, AFTER WHICH, MORCELLIZED LOCAL AUTOGRAFT ROLLED IN AN RHBMP-2 SOAKED ACS WAS PLACED IN THE INTERBODY SPACE. THIS WAS FOLLOWED BY PLACING AN APPROPRIATELY SIZED POLYETHERETHERKETONE CAGE FILLED WITH AUTOGRAFT AND RHBMP-2/ACS, WITH THE DEVICE AND ITS CONTENTS BEING INSERTED OBLIQUELY INTO THE INTERVERTEBRAL SPACE. ONCE THE INTERBODY DISCECTOMY AND ARTHRODESIS WERE COMPLETED, PEDICLE SCREWS AND RODS WERE PLACED AT THE INVOLVED LEVELS. AP AND LATERAL IMAGES WERE OBTAINED TO CONFIRM THE POSITION OF THE GRAFT AND HARDWARE. RADICULOPATHY, NOTED TO BE A MODERATE POST-OPERATIVE COMPLICATION, WAS OBSERVED IN THIS PATIENT, IMMEDIATELY POST L5-S1 PLACEMENT. IN ADDITION, CLINICALLY INSIGNIFICANT HETEROTOPIC OSSIFICATION WAS OBSERVED ON THE TLIF/ANNULOTOMY SIDE. OTHER THAN THE CO-MORBIDITY OF SMOKING, NO OTHER DETAILS WERE MENTIONED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00040 YR Required Intervention