Is hardware explant (removal of medical device) for a fractured C1 screw medically necessary in a patient with a history of occipital cervical fusion and thoracic posterior fixation?

Hardware Explant for Fractured C1 Screw is Medically Necessary

This 37-year-old male with a documented fractured C1 screw causing symptomatic hardware failure, progressive pain, and decreased cervical range of motion meets established criteria for medically necessary hardware removal, regardless of whether the procedure is performed as inpatient or ambulatory surgery.

Medical Necessity Determination: APPROVED

The patient clearly meets the CPB Spinal Surgery criteria for hardware removal, specifically criterion #5: "Symptomatic rod, hook, or screw migration, dislodgment, or breakage" 1. The fractured C1 screw documented on CT imaging (10/27/25) combined with acute worsening of symptoms represents a definitive indication for explantation.

Clinical Rationale Supporting Medical Necessity

Hardware Failure Documentation

• CT cervical spine definitively demonstrates C1 screw fracture, confirmed on both CT (10/27/25) and plain radiographs (10/31/25) 1
• X-ray findings show "unchanged fracture of the right pedicle screw" indicating established hardware failure 1
• Additional concern exists for T11 screw loosening with "increased lucency surrounding the right T11 screw" on thoracic imaging 1

Symptomatic Presentation

• Progressive posterior neck pain over one year with acute exacerbation following minor trauma (sleeping on couch) 1
• Significant decrease in cervical range of motion beyond expected post-fusion limitations 1
• Tenderness to palpation over right cervical paraspinous muscles indicating local inflammatory response to hardware failure 1
• Functional impairment preventing work as HVAC technician, demonstrating impact on quality of life 1

Failed Conservative Management

• Ice/heat therapy provided no relief 1
• Muscle relaxants (Flexeril 5mg) and NSAIDs (Ibuprofen) provided only mild temporary relief 1
• Conservative measures are insufficient for mechanical hardware failure requiring surgical intervention 1

Evidence Supporting Hardware Removal

Timing and Indication

Spinal instrumentation eventually fails from pseudarthrosis and can cause neurological injury if not addressed 2. In this case, the fractured screw represents established hardware failure occurring 8 years post-operatively (original surgery 11/22/17), well beyond the acute post-operative period where implant retention might be considered 1.

Risk of Retained Failed Hardware

• Fractured spinal hardware can migrate and cause catastrophic complications including spinal cord injury and intracranial hemorrhage, as documented in cases of failed atlantoaxial instrumentation 2
• The patient's progressive symptoms and decreased ROM suggest ongoing mechanical irritation from the fractured screw 2
• Retained failed hardware in the upper cervical spine poses particular risk given proximity to critical neurovascular structures 2, 3

Fusion Status Consideration

The original fusion was performed in 2017 (8 years ago), providing adequate time for solid bony fusion to occur 3, 4. Studies demonstrate that posterior C1-C2 fixation typically achieves solid fusion within 3-6 months 4. After 8 years, the structural bone graft should provide sufficient stability to allow hardware removal without compromising spinal stability 3.

Addressing the Ambulatory vs. Inpatient Discrepancy

The MCG designation of this procedure as "ambulatory" does not negate medical necessity—it only addresses the appropriate care setting. The CPB criteria explicitly state that hardware removal is "medically necessary" when symptomatic hardware failure occurs, without restricting the setting 1.

Factors Supporting Inpatient Status

• Complex upper cervical anatomy with proximity to vertebral arteries and spinal cord 5, 3
• History of extensive prior instrumentation (occipitocervical fusion plus thoracic fixation) increases surgical complexity 5
• Potential need for intraoperative assessment of fusion integrity and possible revision if inadequate fusion is encountered 6, 4
• Post-operative monitoring for neurological complications is prudent given the high-risk anatomical location 2, 3

Clinical Precedent

Posterior cervical hardware procedures, particularly at C1-C2, are routinely performed as inpatient procedures due to complexity and potential complications 3, 6, 4. The ambulatory designation in MCG may reflect simpler lumbar hardware removals rather than complex upper cervical cases 1.

Common Pitfalls to Avoid

• Do not delay removal of symptomatic failed hardware in the upper cervical spine, as migration can cause catastrophic neurological injury 2
• Do not assume ambulatory designation negates medical necessity—the two are separate determinations addressing different aspects of care 1
• Ensure adequate imaging confirms solid fusion before hardware removal to prevent post-operative instability 6, 4
• Assess the thoracic hardware given radiographic concern for T11 screw loosening, which may require concurrent attention 1

Recommendation Summary

APPROVE hardware explant as medically necessary based on documented symptomatic hardware failure (fractured C1 screw) meeting established CPB criteria. The inpatient setting is appropriate given the complex upper cervical location, extensive prior instrumentation, and need for post-operative neurological monitoring. The procedure should proceed as scheduled for 11/11/25 1.