S3 · 12/2024 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 12/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2024-00271 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
MAKO BILATERAL PKA SURGERY WAS PERFORMED. HOWEVER, THE CUTTER CHECK COULD NOT BE PASSED JUST BEFORE THE FIRST TIBIAL BONE CUTTING. THE SURGEON HAD NO CHOICE BUT TO DISCONTINUE THE PKA AND CLOSED THE INCISION SITE. REVISION SURGERY (MANUAL PKA) IS PLANNED INSTEAD OF MAKO PKA.
| 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 |