S3 · 06/2025 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 06/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2025-00291 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
AFTER BURRING THE AREA NEAR THE PROXIMAL INTERCONDYLAR EMINENCE OF THE TIBIA WITH MAKOPKA AND PLACING THE TRIAL, IT WAS DISCOVERED THAT THE INTERCONDYLAR EMINENCE HAD BEEN CUT DOWN BY ABOUT 5 MM (1/3) MORE THAN THE PLANNED LINE. THE ATTACHMENT SITE OF THE ACL HAD BECOME UNSTABLE,
| 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 |