BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLYDESDALE SPINAL SYSTEM

    MDR report key: 4962710 · Received August 4, 2015

    Report

    Report Number
    1030489-2015-01879
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    September 1, 2014
    Report Date
    July 7, 2015
    Manufacturer
    MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
    Product Code
    MAX
    PMA / PMN Number
    K100175
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: SEIJI OHTORI, SUMIHISA ORITA, KAZUYO YAMAUCHI, YAWARA EGUCHI; ¿MINI-OPEN ANTERIOR RETROPERITONEAL LUMBAR INTERBODY FUSION: OBLIQUE LATERAL INTERBODY FUSION FOR LUMBAR SPINAL DEGENERATION DISEASE.¿ MEAN AGE: 67 YEARS, MALE: 17, FEMALE: 18. (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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 35 PATIENTS WITH DEGENERATED SPONDYLOLISTHESIS, DISCOGENIC PAIN, AND KYPHOSCOLIOSIS WERE EXAMINED. ALL PATIENTS UNDERWENT OLIF SURGERY (USING A CAGE AND BONE GRAFT FROM THE ILIAC CREST) WITH OR WITHOUT POSTERIOR DECOMPRESSION, WITHOUT REAL TIME ELECTROMYOGRAPHY MONITORING. POSTERIOR SCREWS WERE USED IN ALL PATIENTS. A CAGE FILLED WITH BONE GRAFT FROM THE ILIAC BONE WAS USED IN THIS STUDY. THE OLIF PROCEDURE WAS PERFORMED FROM 1 TO 4 LEVELS FOR A TOTAL OF 45 LEVELS IN 35 PATIENTS. OPEN PEDICLE SCREWS (8 PATIENTS), PERCUTANEOUS PEDICLE SCREWS (22 PATIENTS), OR CORTICAL BONE TRAJECTORY SCREWS (5 PATIENTS) WERE USED FOR POSTERIOR FIXATION. POSTERIOR DECOMPRESSION WAS PERFORMED IN 18 OF THE 35 PATIENTS. ADVERSE EVENTS IN ONE OF THE CASE, INJURY AND MUSCLE WEAKNESS WAS REPORTED AS COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506999 CLYDESDALE SPINAL SYSTEM INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Other