BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLYDESDALE SPINAL SYSTEM

    MDR report key: 4971235 · Received August 5, 2015

    Report

    Report Number
    1030489-2015-01935
    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. 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) 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 (B)(4) ORTHOPEDIC ASSOCIATION(B)(4) SCORE AND PRESENCE/ABSENCE OF COMPLICATIONS. MEAN INTRAOPERATIVE BLOOD LOSS WAS 98 ML. MEAN SDA CHANGED FROM 6.8 DEGREES PREOPERATIVELY TO 12.8 DEGREES POSTOPERATIVELY. MEAN %SLIP CHANGED FROM 17.6% TO 7%, AND MEAN DH CHANGED FROM 5.2 MM TO 9.2 MM. MEAN CSA CHANGED FROM 50.5 MM2 TO 86.2 MM2, RECORDING A DILATATION RATE OF 70.7%. REGARDING COMPLICATIONS, TRANSIENT MUSCULAR WEAKNESS INVOLVED IN HIP FLEXION WAS NOTED IN A PATIENT, AND ADDITIONAL LAMINECTOMY WAS PERFORMED LATER IN 2 PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512693 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 Required Intervention