Phantom Minimally Invasive Surgery (MIS) Lapidus System

Curved osteotome and large curette available in set to further support in preparation, de-rotation and intermetatarsal correction of the joint, as needed

• Complementary with the Phantom Intramedullary Nail
• Developed to provide a structurally sound construct that minimizes hardware prominence for the Lapidus arthrodesis procedure
• The uniform force through the nail allows for a stable construct that is intended to promote primary healing throughout the fusion site¹
• Helps preserve periosteum due to the intramedullary construct
• The Phantom® Nail may be inserted with a minimum of three stab incisions

The Small Bone Phantom® Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.

The Paragon 28® Small Bone Phantom® Intramedullary Nail System implants are not designed or sold for any use except as indicated. Use of the Small Bone Phantom® Intramedullary Nail System is contraindicated in the following situations:

• Active, suspected, or latent infection in the affected area
• Patients who are physiologically or psychologically inadequate
• Patients previously sensitized to titanium
• Longitudinal splits or longitudinal fractures
• Insufficient quantity or quality of bone to permit stabilization, conditions that retard healing (not including pathological fractures) and conditions causing poor blood supply
• Open epiphyseal plates
• In patients where there is a possibility for conservative treatment
• Indications not included in the INDICATIONS FOR USE

• Re-operation to remove or replace implants may be required at any time due to medical reasons or device failure.
• If corrective action is not taken, complications may occur.
• Use of an undersized implant in areas of high functional stresses may lead to implant fracture and failure.
• Plates and screws, wires, or other appliances of dissimilar metals should not be used together in or near the implant site.
• The implants and guide wires are intended for single use only.
• Instruments, guide wires, and screws are to be treated as sharps.
• Do not use other manufacturers’ instruments or implants in conjunction with the Small Bone Phantom® Intramedullary Nail System.

In any surgical procedure, the potential for complications and adverse reactions exist. The risks and complications with these implants include:

• Loosening, deformation, or fracture of the implant
• Acute postoperative infections and late infections with possible sepsis
• Migration, subluxation of the implant with resulting reduction in range of movement
• Fractures resulting from unilateral joint loading
• Thrombosis and embolism
• Wound hematoma and delayed wound healing
• Temporary and protracted functional neurological perturbation
• Tissue reactions as a result of allergy or foreign body reaction to dislodged particles
• Corrosion with localized reaction and pain
• Pain, a feeling of malaise, or abnormal sensations due to the implant used
• Bone loss due to stress shielding

All possible complications listed here are not typical of Paragon 28®, Inc. products but are in principle observed with any implant. Promptly inform Paragon 28®, Inc. as soon as complications occur in connection with the implants or surgical instruments used. In the event of premature failure of an implant in which a causal relationship with its geometry, surface quality or mechanical stability is suspected, please provide Paragon 28®, Inc. with the explant(s) in a cleaned, disinfected and sterile condition. Paragon 28®, Inc. cannot accept any other returns of used implants. The surgeon is held liable for complications associated with inadequate asepsis, inadequate preparation of the osseous implant bed in the case of implants, incorrect indication or surgical technique or incorrect patient information and consequent incorrect patient behavior.