S3 · 04/2025 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 04/2025 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2025-00130 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
REPORTED EVENT: SURGEON COMPLAINED THAT DURING THE MAKO TKA SURGERY ON (B)(6) 2025, AFTER COMPLETING THE BONE CUTS, HE NOTICED AN INJURY IN THE PATIENT'S POPLITEAL. DOES THE CASE REFER TO A PRIMARY IMPLANT OR A REVISION? PRIMARY THE EVENT WAS NOT CONFIRMED BECAUSE THE PRODUCT WAS
| 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 |