BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLYDESDALE SPINAL SYSTEM

    MDR report key: 3965203 · Received July 29, 2014

    Report

    Report Number
    1030489-2014-03342
    Event Type
    Injury
    Date Received
    July 29, 2014
    Report Date
    July 4, 2014
    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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NEITHER DEVICE NOR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN A LITERATURE ABSTRACT THAT A STUDY WAS CONDUCTED WHICH INCLUDED 7 PATIENTS (1 MAN, 6 WOMEN; MEAN AGE AT SURGERY, 64 YEARS) WHO UNDERWENT OLIF IN OR AFTER JULY 2013. OF THE PATIENTS, 2 HAD MULTIPLY OPERATED BACK AND 5 HAD SPINAL DEFORMITY. OLIF WAS PERFORMED AT A SINGLE (N=1), DUAL (N=2) OR TRIPLE (N=4) LEVEL(S). THE TREATED INTERVERTEBRAL LEVELS WERE T12/L1 (N=1), L1/2 (N=4), L3/4 (N=4), L2/3 (N=6), AND L4/5 (N=2, EACH PERFORMED TWICE). IN ALL CASES, OLIF WAS FOLLOWED BY FIXATION WITH SPINAL INSTRUMENTATION VIA POSTERIOR APPROACH. THE MEAN OPERATIVE TIME WAS 7 HOURS AND 55 MINUTES. THE MEAN BLOOD LOSS WAS 1322ML. THE 2 PATIENTS WITH LUMBER DEGENERATIVE DISEASE HAD LEG PAIN/NUMBNESS ASSOCIATED WITH INTERVERTEBRAL INSTABILITY BEFORE THE SURGERY, BUT THE LEG SYMPTOMS WERE IMPROVED POSTOPERATIVELY WITHOUT SURGERY OF THE INTRA-SPINAL CANAL. IN THE 5 PATIENTS WITH SPINAL DEFORMITY, THE MEAN COBB ANGLE OF THE TREATED INTERVERTEBRAL LEVELS CHANGED FROM 33°AT PRE-OP. TO 15°AFTER OLIF ALONE (CORRECTION RATE, 51%) AND TO 8°AT POST-OP. (CORRECTION RATE, 74%). MEANWHILE, THE MEAN KYPHOSIS OF THE OLIF OPERATED LEVELS MEASURED ON THE SAGITTAL PLANE WAS 11°AT PRE-OP, 5°AFTER OLIF DURING THE SURGERY, AND 8°AT POST-OP. COMPLICATIONS INCLUDED EPIDURAL HEMATOMA TREATED WITH FURTHER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442241 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 00064 YR Required Intervention