S3 · 06/2021 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 06/2021 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2021-00113 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
DURING A MAKO HIP CASE, MANUAL REAMING WAS ENABLED. THE MEDIAL DISTANCE REMAINING NUMBER SHOWED WE STILL HAD OVER 3MM TO GO, HOWEVER THE SURGEON WENT THROUGH THE MEDIAL WALL. ADDITIONALLY, THE 3D BONE MODEL SHOWED THAT WE WENT THROUGH THE MEDIAL WALL, WHILE THE MEDIAL DISTANCE TO
| 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 |