EFFECTIVE July 23, 2023
Patient Risk Information
For important risk information, please refer to the Revon™ Screw Screw System Instruction For Use - click here.
Voom Medical Devices, Inc., manufacturers the Revcon Screw System used to correct your bunion using the Bunionplasty® 360 Bunion Repair™ procedure. Individual results may vary and are dependent on many factors, which many are indicated on this page below. Not all patients are candidates for surgery, this product and/or procedure. The Bunionplasty® 360 Bunion Repair™ procedure using the Revcon™ Minimally Invasive Screw System is a surgical procedure and should be considered and not taken lightly. .Only your doctor can advise if the Bunionplasty® 360 Bunion Repair™ procedure and/or the Revcon™ Minimally Invasive Screw System is right for you, your specific foot condition(s), your medical condition(s) and your individual circumstances.
Please consult with a doctor for complete information regarding the risks, benefits, post-surgical protocols, and/or complications associated with this implant(s) and/or procedure(s). This information provided on this page throughout the website, www.voomdevices.com, is available for your review in advance for your consultation with a doctor and/or trained surgeon. In preparation of your doctors visit, we encourage you to read this information on the risks of this surgical Bunionplasty® procedure and the Revcon™ implants. Any questions you may have should be discussed with your doctor, so you can make an informed decision as to whether this procedure is right for you.
What are the risks associated with the Bunionplasty® 360 Bunion Repair™ procedure and/or the Revcon™ Minimally Invasive Screw?1
Individual results may vary with any medical and/or surgery treatment, including this surgical procedure and implant. There are potential risks of a surgical procedure, which include but are not limited to:
- Infection (acute and/or chronic)
- Pain (acute and/or chronic)
- Adverse and/or allergic reactions to foreign material, a foreign body and/or other implanted materials
- Redness and/or swelling of the operated areas
- Damage to blood supply/circulation (such as blood clots)
- Poor healing of incisions and/or bones
- Damage to nerves (burning, tingling, numbness)
- Permanent swelling/enlargement of toe(s), foot/feet and/or leg
- Condition may get worse
- New structural condition may develop (such as hallux varus)
- Disability (temporary or permanent)
- Bad or allergic reaction to anesthesia
- Swollen toe/stiff toe/shorter toe/lifted toe
- Failure of the incisions and/or bones to heal
- Delayed and/or absent bone healing (delayed union, nonunion)
- Loss of correction or loss of anatomic position (malunion)
- Excessive bleeding
- Loss of toe, foot, limb or life
- Operation/procedure/treatment may not work
- Painful and/or large scars
- Pain/discomfort and/or abnormal sensations related to the presence of the implant
- Significant or permanente pain (such as CRPS - Chronic Regional Pain Syndrome)
- More treatment or surgery may be needed
- Revision surgery and/or removal of the implant(s)
- Callus and/or sore may develop on the foot
- Stroke/heart attack/death
- Paralysis/paraplegia/quadriplegia
- Loosening, bending, cracking, fracture and/or breakage of the implant(s)
- Fracture/break or dislocation of a bone(s)
- Loss of fixation of bone(s)
- Migration and/or loosening of the implant(s)
- Difficulty in walking/wearing shoes/playing sports
- Decrease in bone density
If any of the following apply, you may not be a candidate for a surgery (please consult your doctor if any of the following exist):
- Active Infection
- Growing patients with open growth plates (skeletal immaturity)
- Blood supply limitations (ex, vascular insufficiency)
- Obesity
- Insufficient quantity or quality of bone (poor bone quality)
- Mental conditions preventing compliance with postoperative care instructions
- Neurologic conditions preventing compliance with postoperative care instructions
- Allergy/sensitivity to implantation of a foreign body and/or the implant materials (in such cases, testing is to be completed prior to implantation of the device)
Only a doctor can advise if the Bunionplasty® 360 Bunion Repair™ procedure with the Revcon™ Minimally Invasive Screw System/Implant(s) is indicated for you and your foot/feet.
Please consult with your doctor for a complete and full understanding of any associated risks of the surgery including, but not limited to, risks outlined here.
Important considerations about your postoperative care and weightbearing after surgery with surgical implants:
Your doctor/surgeon determines your postoperative care, instructions and your weight bearing protocol. Please adhere to your doctor’s/surgeon’s instructions. If you are non-compliant with your doctor/surgeon's prescribed physical activity instructions, then you may compromise your results and cause premature failure of the implant(s), which can occur with any similarly designed/constructed implant(s) for an intended indication. Please consult your doctor/surgeon for a full understanding of the postoperative care associated with the Bunionplasty® 360 Bunion Repair™ procedure.
References
1. Voom Medical Devices Inc Revcon Minimally Invasive Screw System Instructions for Use