S3 · 07/2025 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 07/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2025-00316 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
VERIFICATION FAILED AND SUBSEQUENT AUTO ARM TEST ALSO FAILED. CABLE AND CAMERA CLEANED. ROBOT RESTARTED SEVERAL TIMES. ROBOT REPOSITIONED AND CAMERA ANGLE CHANGED. THE SURGERY WAS CANCELLED AND THE NEXT SURGERY IN THE OPERATING ROOM TOOK PLACE APPROXIMATELY ONE HOUR AFTER WE STAR
| 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 |