S3 · 04/2022 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 04/2022 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR MW5108838 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
MAKO 2.7 DEGREE ANGLED SAGITTAL SAW WOULD NOT LOCK ONTO THE MAKO ROBOTIC ARM. COMPANY REPRESENTATIVE (B)(6) PRESENT. FDA SAFETY REPORT ID # (B)(4).
| 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 |