BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, PEDICLE SPINAL FIXATION

    MDR report key: 6491214 · Received April 13, 2017

    Report

    Report Number
    2520274-2017-11289
    Event Type
    Injury
    Date Received
    April 13, 2017
    Report Date
    March 17, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. CHOI, W.S., ET AL (2016) MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1 THROUGH A UNILATERAL APPROACH: TECHNICAL FEASIBILITY AND OUTCOMES. BIOMED RESEARCH INTERNATIONAL, VOLUME 2016, ARTICLE ID 2518394, 8 PAGES. THIS REPORT IS FOR UNKNOWN PEDICLE SCREW, UNKNOWN QUANTITY, UNKNOWN LOT. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    LITERATURE ARTICLE RECEIVED. THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE, CHOI, W.S., ET AL (2016) MINIMALLY INVASIVE TRANSFORAMINAL LUMBAR INTERBODY FUSION AT L5-S1 THROUGH A UNILATERAL APPROACH: TECHNICAL FEASIBILITY AND OUTCOMES. BIOMED RESEARCH INTERNATIONAL, VOLUME 2016, ARTICLE ID 2518394, 8 PAGES. FROM MAY 2012 TO AUGUST 2014, 22 CONSECUTIVE PATIENTS WHO HAD BEEN DIAGNOSED WITH DEGENERATIVE SPINAL DISEASES AT THE L5-S1 SEGMENT UNDERWENT MIS-TLIF AT AN INSTITUTION. AFTER COMPLETION OF DISCECTOMY AND FORAMINAL DECOMPRESSION, A BANANA-SHAPED CAGE (8 PATIENTS) (CRESCENT, MEDTRONIC SOFAMOR DANEK, TENNESSEE, USA) OR STRAIGHT CAGE (13 PATIENTS) (OPAL, DEPUY-SYNTHES SPINE, MASSACHUSETTS, USA) FILLED WITH MORSELIZED BONE FRAGMENTS OBTAINED FROM LAMINO FACETECTOMY MIXED WITH DEMINERALIZED BONE MATRIX (DBM) IS INSERTED INTO THE DISK SPACE. THE DISK SPACE VENTRAL TO THE INSERTED CAGE IS ALSO PACKED WITH MORSELIZED BONE AND DBM. THEN, PERCUTANEOUS PEDICLE SCREWS (SEXTANT, MEDTRONIC SOFAMOR DANEK, TENNESSEE, USA, OR VIPER 2, DEPUY-SYNTHES SPINE, MASSACHUSETTS, USA) ARE INSERTED UNDER FLUOROSCOPIC GUIDANCE, AND ADEQUATE SIZED RODS ARE FITTED. A TOTAL OF 22 PATIENTS (7 MALE, 14 FEMALE) MET THE INCLUSION CRITERIA. ONE PATIENT WAS LOST TO FOLLOW-UP (DROP RATE 4.5%). THERE WERE A TOTAL OF 21 OPERATED LEVELS. THE MEAN AGE OF PATIENTS WAS 61.5 ± 11.2 YEARS. MEAN FOLLOW-UP PERIOD WAS 17.9 ± 8.8 (12¿36) MONTHS. ON MRI OF THE LUMBAR SPINE, 12 PATIENTS HAD SPINAL STENOSIS WITHOUT SPONDYLOLISTHESIS, 8 PATIENTS HAD SPINAL STENOSIS WITH SPONDYLOLISTHESIS, AND 2 PATIENTS HAD FORAMINAL STENOSIS. IT CANNOT BE DETERMINED WHETHER THE COMPLICATIONS OCCURRED WITH THOSE PATIENTS IMPLANTED WITH THE BANANA-SHAPED CAGE (CRESCENT, MEDTRONIC SOFAMOR DANEK, TENNESSEE, USA) OR STRAIGHT CAGE (OPAL, DEPUY-SYNTHES SPINE, MASSACHUSETTS, USA) COMPLICATIONS: ONE CASE OF SCREW MALPOSITION WHICH REQUIRED REOPERATION. THIS IS REPORT 2 OF 2 FOR (B)(4). THIS REPORT IS FOR AN PEDICLE SCREW. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273665 ORTHOSIS, PEDICLE SPINAL FIXATION MNI SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention