Orthofix M6-C Artificial Cervical Disc Gebrauchsanweisung Seite 6

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Anterior Cervical Surgery Risks
Anterior cervical surgical risks are, but may not be limited to:
• Infection/abscess/cyst, localized or systemic
• Injury or damage to the trachea, esophagus, nerves or blood vessels
• Dysphagia
• Hoarseness
• Vocal cord paralysis
• Paresis
• Recurrent laryngeal nerve palsy
• Soft tissue damage
• Spinal cord damage
• Dural tear with cerebrospinal fluid leakage
• Arm weakness or numbness
• Death
Cervical Artificial Disc Risks
Risks specific to cervical artificial discs, including the M6‑C Artificial Cervical Disc, are but may not be limited to:
• Infection/abscess/cyst, localized or systemic
• Allergic reaction to the implant materials
• Inflammation
• Granuloma
• Implant failure
• Device migration
• Device translation
• Device subsidence
• Device fatigue or fracture or breakage
• Device instability
• Separation of device components
• Placement difficulties, device malposition
• Improper device sizing
• Excessive device height loss
• Wear debris (manifested as osteolysis and/or device damage/breakage/
failure)
• Disc space collapse
• Material degradation (manifested as osteolysis and/or device damage/
breakage/failure)
• Excessive facet loading
• Kyphosis or hyper‑extension
• Loss of flexibility
• Asymmetric range of motion
The following additional adverse effects may occur:
•
Resorption or osteolysis, with known or suspected infection/infected abscess/infected cyst, leading to surgical intervention
with or without explantation. (remote probability)
•
Resorption or osteolysis, without infection/infected abscess/infected cyst, leading to surgical intervention with or without
explantation. (remote probability)
•
Resorption or osteolysis, with or without known or suspected infection/infected abscess/infected cyst, not leading to surgical
intervention. (improbable)
Assessment of the above adverse effects is based on the following definitions of incidence.
Improbable
< 0.1%
(~ 1/1000)
6
Remote probability
> 0.1% ‑ <0.5% > 0.5% ‑ < 2.0%
(~ 1/200)
• Bowel, bladder or sexual dysfunction
• Nerve root injury
• Airway obstruction
• Epidural hematoma or bleeding
• Epidural fibrosis
• Vertebral body fracture
• Dysesthesia or numbness
• Paresthesia
• Unresolved pain
• Surgical intervention at incorrect level
• Need for supplemental fixation
•Spinal instability
• Vertebral body fracture
• Spinal cord damage, cord compression, paralysis, or quadriplegia
that is temporary or permanent
• Development of spinal conditions, including but not limited to
spinal stenosis, spondylolisthesis, or retrolisthesis
• Dural tear with cerebrospinal fluid leakage
• Soft tissue damage
• Epidural fibrosis
• Nerve injury, paralysis or weakness that is temporary or
permanent
• Injury or damage to the trachea, esophagus, or blood vessels
• Epidural hematoma or bleeding
• Dysesthesia or numbness
• Paresthesia
• Failure to relieve symptoms including unresolved pain
• Additional surgery due to loss of fixation, infection or injury
• Heterotopic ossification (Grades 1‑4); Spontaneous fusion due to
heterotopic ossification, development of bridging bone or
osteophytes
• Epidural hematoma or bleeding
• Dysesthesia or numbness
• Periarticular calcification and/or fusion
• Removal, revision, reoperation or supplemental fixation of the
disc
• Peri‑prosthetic osteolysis, bone loss, or bone resorption
• Death
Low probability
> 2.0% ‑ < 4.0%
(~ 1/50)
Probable High probability
> 4.0%
(~1/25) (>1/25)