Our Physicians Suggest the Following Infuse Bone Criteria:
- Recombinant Human Bone Morphogenetic Protein (rhBMP) – Bioengineered liquid bone protein housed in a small container or cage that is implanted into the spine (spinal fusion surgery) – encourages bone growth
- rhBMP-2 (contained in InFuse Bone Graft) has received FDA premarket approval for fusion of the lumbar spine in skeletally mature patients with Degenerative Disc Disease (DDD) at one level from L2-S1 and for healing of acute, open tibial shaft fractures stabilized with an IM nail and treated within 14 days of the initial injury. rhBMP-2 is also approved for certain oral and maxillofacial uses.
- FDA Safety Alert: Note that the safety and effectiveness of rhBMP in the cervical spine have not been demonstrated and these products are not approved by FDA for this use.
- Complications Due to Off-Label Use of Bone Graft in Cervical Surgery Procedures
- Patients not told about off-label nature of the surgery, and/or were not told of the potential risks of serious and permanent injuries related to such use of Infuse
- Patients not allowed to make an informed decision whether or not to proceed with surgery
Ectopic Bone Growth, swelling of neck and throat tissue resulting in compression of airway and nerves – leading to respiratory depression and other complications
Areas to be focused in Medical Records Review
Medical and Surgical History:
Medical issues directly or indirectly related to spine – particularly degenerative disc disease, spine surgeries, prior infuse graft use
2. Bone Infuse Graft Surgery Consultation
Need and Indication for Spine Surgery, Use of Infuse graft
Whether patient right candidate for infuse use? – Skeletally mature i.e. >18 years of age
Lumbar Spine Infuse – informed consent
Cervical Spine Infuse – whether patient informed of off-label use, informed decision/consent made
Contraindications for Infuse Graft Usage: rhBMPs are contraindicated for all uses in patients who are skeletally immature (<18 years of age) or pregnant, and in those with a known hypersensitivity to the specific rhBMP, bovine Type 1 collagen or to other components of the formulations.
3. Infuse Graft Surgery Details:
Detailed Operative Report
Post Operative Follow up
Entire Hospital Stay in detail
Infuse Graft Details: Product Label Details – i.e. Name of Infuse, implant, Manufacturer, Lot No., Reference No.
If not Medtronic Infuse Graft – Report to client
4. Infuse Graft Complications
What were the patient complaints?
When was this first reported? Complications occur 2 to 14 days postoperatively
Swelling of neck and throat tissue resulting
Compression of airway and/or neurological structures in the neck
Difficulty swallowing, breathing and speaking
Ongoing/Chronic Radiating Pain (neuritis, radiculopathy, or radiculitis)
Male Sterility, retrograde ejaculation
Ectopic Bone Growth
Inflammatory Cyst Formation
5. Management of Complications
Medical Assessment and Diagnosis
Medical and Surgical Management of Complications
Treatment: Respiratory support with intubation, anti-inflammatory medication, tracheostomy, surgeries to drain the surgical site
Revision Surgery (if done): Operative Report, Operative Findings documenting infuse complication, Post Operative Follow up, Entire Hospital Stay in detail
6. Condition of the patient after management of complication7.
7. Current condition of the patient
If death, review autopsy report and death certificate to document the cause of death
Missing records notification to Client related to
- Hospital Records for Infuse Graft Surgery, Hospital Records for Complication Management
Spine Surgeon Opinion relating to injuries, complications if needed