Orthofix M6-C Artificial Cervical Disc Gebrauchsanweisung Seite 3

CDM‑625
CDM‑725
CDL‑627
CDL‑727
CDM‑635L
CDM‑735L
CDL‑637L
CDL‑737L
I U
ndIcatIons for se
The M6‑C Artificial Cervical Disc System is intended for use in skeletally mature patients undergoing primary surgery for
treatment of symptomatic disc diseases of the cervical spine at any one level or multiple levels between C3 through C7, who
have not responded to non‑operative conservative management.* The disease state is demonstrated by signs and/or symptoms
of disc herniation, osteophyte formation, or loss of disc height.
* The non-operative conservative management requirement may be waived in the cases of myelopathy requiring immediate
treatment and/or cervical radiculopathy with worsening neurological functions (i.e. motor weakness).
c
ontraIndIcatIons
The M6‑C Artificial Cervical Disc should not be implanted in patients with the following conditions:
•
Be ≥70 years of age.
•
Have a bone mineral density with T‑score ≤‑1.5 as determined by spine DXA if male ≥60 years of age or female ≥50 years
of age.
•
Have an active systemic infection or infection at the operative site.
•
Have a dental infection
•
Have sustained an osteoporotic fracture of the spine, hip or wrist.
•
Have received medications (e.g., methotrexate, alendronate) that interfere with bone and mineral metabolism within 2 weeks
of the planned date of the index surgery.
•
Have any medical or surgical condition precluding the potential benefit of spinal surgery.
•
Have a history of endocrine or metabolic disorders (e.g., Paget's disease) known to affect bone and mineral metabolism.
•
Have rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV or active hepatitis.
•
Have spinal metastases.
•
Have a known allergy to titanium, polyurethane, polyethylene or ethylene oxide residuals.
•
Have type 1 or type 2 diabetes requiring daily insulin management.
•
Be pregnant.
•
Have axial neck pain as the solitary symptom.
•
Have severe cervical myelopathy as evidenced by any sign of gait disturbance, unilateral or bilateral leg weakness, and/or
uncontrollable bowel/bladder symptoms related to cervical spine disease.
•
Require a treatment (e.g., posterior element decompression) that destabilizes the spine.
•
Have advanced cervical anatomical deformity (e.g., ankylosing spondylitis, scoliosis) at the operative site.
•
Have advanced degenerative changes (e.g., spondylosis) at the index vertebral level as evidenced by:
-
Bridging osteophytes;
-
Average ROM <4º;
-
Disc height <25% of the AP width of the inferior vertebral body; as measured in a lateral radiograph in neutral position;
-
Subluxation >3mm;
-
Kyphotic deformity at >20º on neutral radiographs.
p
recaUtIons
•
Read and understand the M6‑C Artificial Cervical Disc System Instructions for Use prior to use.
•
The M6‑C Artificial Cervical Disc is intended to be used with the M6‑C Manual Surgical Instruments.
•
Refer to the M6‑C Artificial Cervical Disc Operative Technique Manual for implantation instructions.
Table 1: M6‑C Artificial Cervical Disc Catalog Number and Size
6 Medium (15mm W x 12.5mm D x 6mm H)
7 Medium (15mm W x 12.5mm D x 7mm H)
6 Large (17mm W x 14mm D x 6mm H)
7 Large (17mm W x 14mm D x 7mm H)
6 Medium‑Long (15mm W x 15mm D x 6mm H)
7 Medium‑Long (15mm W x 15mm D x 7mm H)
6 Large‑Long (17mm W x 16mm D x 6mm H)
7 Large‑Long (17mm W x 16mm D x 7mm H)
Description
en
Provided Sterile
Yes
Yes
Yes
Yes
Yes
Yes
Yes
Yes
3