S3 · 06/2025 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 06/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2025-00293 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
AS ORIGINALLY REPORTED BY MPS: "PATIENT STARTED WITH 6 DEGREES OF VARUS. MAKO SAID HIS FINAL LIMB ALIGNMENT WAS 1 DEGREE OF VALGUS BUT THE PATIENT IS NOW IN 5 DEGREES OF VALGUS. SURGEON WANTS TO UNDERSTAND WHY. CASE TYPE / APPLICATION: TKA 2.0" ADDITIONAL INFORMATION: SURGERY ORI
| 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 |