S3 · 11/2020 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 11/2020 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2020-00345 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
WRONG SIZE ONLAY TIBIAL INSERT WAS INSERTED INTO PATIENT. I WRONGLY GRABBED A SIZE 4 INSERT INSTEAD OF SIZE 5 AND SHOWED BOXES TO NURSE BEFORE OPENING, SURGEON REFUSED TO LOOK AT BOXES TO CONFIRM. THIS RESULTED IN WRONG SIZE BEING PUT IN PATIENT. BOTH ASSISTANT AND SURGEON DIDN¿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 |