S3 · 05/2025 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 05/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2025-00242 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE FOLLOWING WAS REPORTED "ARM WOULD NOT ALIGN TO CORRECT CUTTING PLAN FOR PLANAR WORKFLOW. WENT THROUGH ENTIRE TROUBLESHOOTING ALGORITHM AND WAS NOT ABLE TO CORRECT. SURGEON CLOSED PATIENT UP AND WAS UNABLE TO COMPLETE CASE USING MAKO. CASE TYPE / APPLICATION: PKA 3.0".
| Sev | Date | Company | Event |
|---|---|---|---|
| S2 | 2015-06-30 | Hocoma | Proximal tibia fracture in a patient with incomplete spinal cord injury associated with robotic treadmill training |