S3 · 11/2023 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 11/2023 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2023-00167 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE FOLLOWING DEVICES WERE ALSO LISTED IN THIS REPORT: DEVICE; MCK TIBIAL BASEPLATE-RM/LL-SZ 3; CAT# 180613; LOT# 26300522-01. DEVICE; MCK FEMORAL-RM-LL-SZ 3; CAT# 180513; LOT# A6WV-1. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PA
| 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 |