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RibLoc® U Plus Chest Wall Plating System
These instructions are intended for the Operating Surgeon and
US
assistant healthcare Professionals. The US instructions are intended
for users in the United States and its territories.
DESCRIPTION
The RibLoc® U Plus Chest Wall Plating System consists of bone plates, screws, and accessories designed to
provide fixation for fractures, fusions, and osteotomies of the ribs, and reconstructions of the chest wall.
Anatomical dimensions determine the size and shape of implant used.
appropriate size, and contour the plate if necessary, to match the patient's anatomy for close adaptation and
firm seating with adequate support.
INDICATIONS FOR USE
The RibLoc® U Plus Chest Wall Plating System is intended to stabilize and provide fixation for fractures,
fusions, and osteotomies of the ribs, and for reconstructions of the chest wall, and sternum.
CONTRAINDICATIONS
Contraindications for this system are active or latent infection, sepsis, insufficient quantity or quality of
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bone/soft tissue, and material sensitivity. If metal sensitivity is suspected, tests should be performed
prior to implantation.
Patients who are unwilling or incapable of following postoperative care instructions are contraindicated
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for this device.
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This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the
cervical or lumbar spine
WARNINGS
For safe and effective use of this implant, the surgeon must be thoroughly familiar with the implant, the
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methods of application, the instruments, and the recommended surgical technique for this device.
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For safe and effective use of this implant with the U Plus 90 Instrumentation, the surgeon must be
thoroughly familiar with the W&H Implantmed or Amadeo units and the Surgical Contra-handpiece
IFUs. IFUs available at http://www.wh.com and https://med.wh.com.
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Surgeons must carefully consider the likelihood of healing being achieved when plating fractures,
osteotomies, or reconstructions of the chest wall. The implant is only designed to withstand loading
during a reasonable healing time period and is not intended to be a permanent prosthesis.
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Surgeons must consider a possible need for emergent reentry, such as sternotomy, before plating the
sternum.
Improper insertion of the device during implantation can increase the possibility of loosening or
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migration.
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A poorly contoured plate may result in an abnormal load on bones or may result in patient discomfort.
Instructions for use
U.S. English – US / PAGE 2
Rx only
The surgeon must select the
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