Cousin Biotech ResCUBE Gebrauchsanweisung Seite 2

Instructions for use
DESCRIPTION
The ResCUBE device is an implant with the purpose of correction and stabilisation of the spine during fusion of the
instrumented levels.
It consists of:
 A braid forcorrection and stabilisation of the levels, through tension;
 A malleable lamella for guidance of the braid during surgery and attached to the braid through a thermal-retractable
sleeve. The malleable metal lamella and the sleeve linking it to the braid are not intended for long term implantation
and must be removed after placement of the implant.
 A connector holding the tension on the braid
MATERIALS
Braid
Connector
Malleable lamella
Shrink Sleeve
All used materials are non resorbable and not of human or animal origin.
INDICATIONS
ResCUBE is indicated for the following surgical treatments:
 Spinal trauma surgery that can be treated with sublaminar, interspinous or facet ligamentoplasty.
 Spinal degenerative pathologies, as an adjunct to intervertebral fusion
 Spinal reconstructive surgery incorporated into constructions with the aim of correcting spinal deformities such as
scoliosis, kyphosis and spondylolisthesis.
CONTRA-INDICATIONS
The ResCUBE device should not be usedin the following cases:
 General or local infection in the intervention area
 Local inflammation in the intervention area
 Pregnancy
 Immune deficiency
 Any pathology affecting bone metabolism, such as osteopenia, osteoporosis, metastasis, tumour... can compromise
the expected mechanical support of the implant, and therefore, the success of the surgery
 Insufficient tissue or muscle coverage
 Suspected or confirmed sensitivity to at least one of the components
 Excess weight or obesity can lead to mechanical overload on the implant, compromising the success of the surgery
 Any mental state or activity level incompatible with the postoperative follow-up can compromise the success of the
surgery
 Smoking patients are more likely to present a non-satisfactory bone fusion or non-fusion
 Any other contra-indication to instrumented surgery of the spine
The described contra-indications can be absolute or relative and must be evaluated by the surgeon prior to any implant
decision.
POTENTIAL UNDESIRABLE SECONDARY EFFECTS
In addition to the risks linked to instrumented spine surgery, the following effects can be observed in rare cases:
 Unusual sensations, discomfort or pain due to the presence of the implant
 Migration, deformation or breakage of one or several components of the implant that can cause neurological, mobility
complications or pain
 Infection, allergic or inflamatory reactions due to the components of the implant, or to the presence of micro particles
(metallosis)
 Halting the growth of instrumented levels
 Partial or total loss of correction
 Intra-operative or post-operative lesions, fissures or fractures, in case of insufficient bone density
 Pseudo arthritis
 Pulmonary complications
 Death
In case of undesirable secondary effects, a second surgery may be necessary, in order to remove or replace one or
several implants.
ResCUBE ™
Ligament System for Spine Stabilisation
Single use sterile product
Polyethylene Terephtalate
Titanium TA6V ELI
Stainless Steel
Polyolefin
Page 2 / 20
For long
term implantation
Not for long
term implantation
en