BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 4646409 · Received March 31, 2015

    Report

    Report Number
    1030489-2015-00684
    Event Type
    Injury
    Date Received
    March 31, 2015
    Date of Event
    December 1, 2012
    Report Date
    March 3, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    P000058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: SAID OSMAN. ENDOSCOPIC TRANSFORAMINAL DECOMPRESSION, INTERBODY FUSION, AND PERCUTANEOUS PEDICLE SCREW IMPLANTATION OF THE LUMBAR SPINE: A CASE SERIES REPORT. INTERNATIONAL JOURNAL OF SPINE SURGERY 6 (2012) 157¿166. MEAN AGE WAS 52.8 YEARS (RANGE, 26 ¿ 85 YEARS). 30 FEMALES, 30 MALES. (B)(6). 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 60 PATIENTS WITH DIAGNOSES OF DEGENERATIVE DISC DISEASE, DEGENERATIVE MOTION SEGMENTS WITH STENOSIS, AND SPONDYLOLISTHESIS, IN WHOM NONOPERATIVE TREATMENTS FAILED, WERE TREATED WITH ENDOSCOPIC TRANSFORAMINAL DECOMPRESSION AND INTERBODY FUSION BY 1 SURGEON IN 2 CENTERS. THE OUTCOME MEASURES WERE AS FOLLOWS: OPERATING TIME, INTRAOPERATIVE BLOOD LOSS, HOSPITAL STAY, VISUAL ANALOGUE SCALE (VAS) SCORES FOR BACK AND LEG PAIN, SCORES ON THE (B)(6) DISABILITY QUESTIONNAIRE, AND POSTOPERATIVE IMAGING STUDIES. A CONSECUTIVE SERIES OF PATIENTS WHO MET THE TREATMENT CRITERIA COMPLETED VAS FORMS AND (B)(6) QUESTIONNAIRES PREOPERATIVELY. SURGICAL PROCEDURES INCLUDED ARTHROSCOPIC DECOMPRESSION OF THE FORAMINA AND THE DISCS; ENDPLATE PREPARATION AND IMPLANTATION OF ALLOGRAFT BONE CHIPS AND BONE MORPHOGENETIC PROTEIN 2 ON ABSORBABLE COLLAGEN SPONGE INTO THE DISC SPACE; AND PERCUTANEOUS IMPLANTATION OF PEDICLE SCREWS. SEXTANT WAS USED IN 17 OF THE PATIENTS. POSTOPERATIVELY, THE PATIENTS AGAIN COMPLETED THE VAS FORMS AND ROLAND-MORRIS QUESTIONNAIRES. THEIR CHARTS WERE REVIEWED FOR OFFICE NOTES, OPERATIVE NOTES, HOSPITAL STAY, MEDICATIONS, AND IMAGING STUDIES. THE LATEST X-RAY AND COMPUTED TOMOGRAPHY SCAN FILMS WERE REVIEWED AND ANALYZED. PATIENTS WERE FOLLOWED UP FOR A MINIMUM OF 6 MONTHS. ALL PATIENTS HAD IMPROVEMENT OF MOTOR FUNCTION. 8 PATIENTS (13%) COMPLAINED OF RESIDUAL DISCOMFORT ON EXTENSION OF THE LUMBAR SPINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212642 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