BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLYDESDALE SPINAL SYSTEM

    MDR report key: 4971238 · Received August 5, 2015

    Report

    Report Number
    1030489-2015-01936
    Event Type
    Injury
    Date Received
    August 5, 2015
    Report Date
    July 8, 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: YUTAKA KOBAYASHI, ICHIRO TORIGOE, YOSHIYASU ARAI, KENICHIRO SAKAI, MAKOTO SOMA, HIDETSUGU MAEHARA, MASAKI TOMORI, TAKASHI HIRAI, HIROKAZU SATO AND ATSUSHI OKAWA; " EVALUATION OF THE EFFECTS OF INDIRECT NEURAL DECOMPRESSION BY LESS INVASIVE LUMBAR SPINAL FUSION WITH OLIF IN PATIENTS WITH LUMBAR DEGENERATIVE SPONDYLOLISTHESIS" MEAN AGE, 65.4 YEARS MALE:2, FEMALE:10. (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 THE STUDY INVOLVED 12 PATIENTS (19 AFFECTED INTERVERTEBRAL SPACES) WHO UNDERWENT OLIF FOR THE TREATMENT OF LUMBAR DEGENERATIVE SPONDYLOLISTHESIS BETWEEN (B)(6) AND (B)(6) 2014 (2 MEN AND 10 WOMEN; MEAN AGE, 65.4 YEARS). IN ALL CASES, SURGERY WAS PERFORMED WITH MYELOGRAPHY, AND THE POSTERIOR PART WAS FIXED WITH PERCUTANEOUS PEDICLE SCREWS (PPS) OR CORTICAL BONE TRAJECTORY (CBT) SCREWS (PPS IN 10 CASES, CBT IN 2 CASES), LAMINECTOMY WAS NOT PERFORMED AND NO DRAIN WAS KEPT INSERTED. FUSION WAS MADE AT 1 INTERVERTEBRAL LEVEL IN 5 CASES AND 2 INTERVERTEBRAL LEVELS IN 7 CASES (L3/4, 11 SPACES; L4/5, 8 SPACES). PARAMETERS ANALYZED WERE INTRAOPERATIVE BLOOD LOSS, CHANGES IN FUSED INTERVERTEBRAL LORDOSIS ANGLE (SEGMENTAL DISC ANGLE [SDA]), SLIP PERCENTAGE (%SLIP) AND DISC HEIGHT (DH) RATED ON LATERAL X-RAY, CHANGES IN THE CROSS-SECTIONAL AREA OF THE DURAL SPACE (CSA) MEASURED BY TRANSVERSE MRI, IMPROVEMENT RATE IN JAPAN ORTHOPEDIC ASSOCIATION (JOA) SCORE AND PRESENCE/ABSENCE OF COMPLICATIONS. THE SURGEON PERFORMED OLIF WITH PPS ON THE SAME DATE, BUT THE NEUROLOGICAL SYMPTOM OF THE PATIENT DID NOT SUBSIDE, SO THE SURGEON CONDUCTED LAMINECTOMY ADDITIONALLY ON A LATER DATE. OSTEOARTHRITIS WAS REPORTED AS A COMPLICATION. BECAUSE OSTEOARTHRITIS AT INTERVERTEBRAL JOINT WAS SEVERE THE DISC HEIGHT APPEARED TO BE RAISED, BUT THE INTERVERTEBRAL JOINTS GOT LOCKED UP AND INDIRECT DECOMPRESSION DID NOT HAVE A POSITIVE EFFECT. JOA SCORE IMPROVEMENT RATE WAS 55%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511633 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 00065 YR