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Case Studies & Outcomes

5,000+ patients. Real outcomes. Real data.

Every implant we ship has a patient and a story behind it. This page brings together the clinical trial cases that validated our technology, the industry-university collaborations that advanced the field, and the patient outcomes that drive our quality system.

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Featured Case · Clinical Trial

Large left temporoparietal skull defect: full workflow, 6-month follow-up.

A representative case from our large-cohort prospective clinical study. The patient presented with a large skull defect in the left temporoparietal region following decompressive craniectomy for severe TBI. The case illustrates the full CT-to-surgery workflow and the 6-month follow-up outcomes.

Case #P-2025-0342

Indication

Severe TBI with decompressive craniectomy. Large, irregular skull defect in the left temporoparietal region. Patient: male, 38 yr.

Workflow (5 stages)

  1. Stage 1 — Clinical intake: CT DICOM + defect description received; medical engineer response within 24 h.
  2. Stage 2 — Image & design: 3D reconstruction → biomimetic patient-specific design → gradient porous micro-architecture → FEA validation (peak von Mises < 440 MPa; micromotion < 50 µm; stress-shielding 0.7–1.3).
  3. Stage 3 — MEI sign-off: Surgeon-engineer review session, signed pre-operative design confirmation.
  4. Stage 4 — Manufacture: EBM build, post-processing (stress relief + wire EDM + CNC), 100% CMM inspection, double-pouch sterile pack.
  5. Stage 5 — Delivery: DHL/FedEx direct to hospital, ±10% backup implant, 5 working days lead time.

Outcome at 6 months

  • Implant integration: 100% — no signs of loosening, migration, or exposure
  • Symmetry: Cranial curvature restored 1:1; facial symmetry recovered
  • Patient-reported aesthetics: Excellent
  • Complications: None observed
  • Re-operation: None required
  • Foreign-body sensation / chronic headache: None
  • Imaging: Post-op CT shows reduced artifacts due to porous design; implant is clearly visible
  • Surgeon assessment: "The MEI workflow changes the surgical experience. By the time the patient is on the table, the geometry is no longer a surprise — it's an execution."
Visual Workflow

From CT scan to 6-month follow-up — five stages.

The visual sequence below shows the key milestones of the featured case.

① Pre-op CT

Large left temporoparietal defect post-DC

② 3D Reconstruction

Biomimetic design + gradient optimisation

③ EBM Build

Ti-6Al-4V ELI, vacuum EBM, 100% CMM

④ Surgical Implant

Direct placement, no shape adjustment

⑤ 6-mo Follow-up

No complications, perfect symmetry

Case Library

Representative case series.

A snapshot of the case types covered by our 5,000+ clinical dataset. The full anonymised case library is available to qualified clinical partners under NDA.

TBI / DC

Severe TBI with decompressive craniectomy

Young 20–50 yr, 70% male. Large irregular defects — often bifrontal. The dominant case type in our dataset, with the strongest complication-rate advantage over conventional mesh / PEEK.

  • Sub-millimetre anatomical match on first placement
  • OR time reduced 30–60 min vs. mesh / PEEK
  • No re-operations for critical failure observed
Aneurysm

Aneurysm rupture reconstruction

40–70 yr. Large irregular defects. The MEI workflow is particularly valuable here — collapse of the "try-fit, re-trim" loop into a single placement.

  • Multi-disciplinary team engagement (neurosurgery + neuro-IR)
  • Single-placement workflow
  • Excellent post-op aesthetic outcomes
Stroke

Ischaemic stroke + DC

Mid 50–70 yr. Hemispheric large-area defects. Patient-matched geometry reduces operative time and improves soft-tissue integration.

  • Hemispheric defect coverage
  • Reduced subcutaneous effusion vs. PEEK
  • Good outcomes in older patient cohorts
Tumour

Brain tumour resection

40–70 yr. Often orbito-frontal or temporal defects. Aesthetic outcome matters — the biomimetic dual-surface design is the right answer.

  • Orbital / temporal contour restoration
  • 1:1 cranial curvature match
  • Excellent patient-reported outcomes
Paediatric

Paediatric congenital deformity

0–10 yr. Dedicated paediatric sizes. Long-term biocompatibility and osseointegration are particularly important for growing skeletons.

  • Paediatric size range
  • Porous surface supports bone ingrowth as child grows
  • Long-term follow-up in registry
Re-do

Reconstruction after prior cranioplasty failure

Re-operation cases with poor soft-tissue envelope or contaminated field. Patient-matched geometry simplifies the case.

  • Several hundred re-do cases in dataset
  • Re-derived geometry from current CT
  • Porous bone-contact supports re-integration
Aggregate Outcomes

Across the 5,000+ patient dataset.

NMPA Class III
< 2%

Total complication rate

vs. 12–18% literature controls

Re-operation
0%

Critical failure re-operation rate

None observed in 5,000+ cases

Patient satisfaction
High

Aesthetic & quality-of-life outcomes

PROMs consistently positive

View the full complication comparison

Looking for a specific case type or indication?

Our full anonymised case library is available to qualified clinical and commercial partners under NDA. Reach out to discuss a specific case, indication, or surgeon engagement.

Request the case library Talk to our team