S3 · 02/2026 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 02/2026 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2026-00098 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THE FOLLOWING INFORMATION WAS PROVIDED: DURING MAKO TKA, WHEN MEASURING THE VIRTUAL GAP, THE INSERTION OF THE MEDIAL COLLATERAL LIGAMENT (MCL) TORE SLIGHTLY WHEN VALGUS STRESS WAS APPLIED. THE TORE PART WAS SUTURED.
| 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 |