Medtronic Infuse Bone Evaluation Criteria

 

Our Physicians in India review thousands of charts per year along with Plaintiff Fact Sheets

Lawsuit Background

  • 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 AlertNote 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
  • Complications:

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

1.        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

Various Consultations

Whether patient right candidate for infuse use? – Skeletally mature i.e. >18 years of age

Preoperative Assessment

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

Severe dysphagia

Paralysis

Ongoing/Chronic Radiating Pain (neuritis, radiculopathy, or radiculitis)

Male Sterility, retrograde ejaculation

Ectopic Bone Growth

Inflammatory Cyst Formation

Cancer

Respiratory Depression

Death

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

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