S3 · 12/2025 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 12/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR MW5180790 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
I AM WRITING IN RELATION TO MY MEDWATCH REPORT (REF: (B)(4)) AND THE ASSOCIATED FDA CDRH CASE REFERENCES (B)(4). I HAVE NOW FINALISED A CONSOLIDATED CROSS-JURISDICTIONAL REGULATORY NOTIFICATION CONCERNING MANUFACTURER-CONTROLLED DATA PATHWAYS AND UNAVAILABLE AUDIT TRAILS WITHIN T
| 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 |