S3 · 10/2020 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 10/2020 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2020-00332 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
DURING A PRIMARY RIGHT MAKO PKA 3.0 CASE THE ROBOTIC ARM LOCKED MID CASE. THE TIBIA AND POSTERIOR FEMORAL CUT WERE ALREADY PERFORMED. WHEN THE ERROR APPEARED ON SCREEN, THE ARM LOCKED JUST AS THE SURGEON WAS ABOUT TO BEGIN BURRING. I RELEASED THE ARM AND ADVISED THE SURGEON, TO R
| 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 |