S3 · 02/2021 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 02/2021 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2021-00018 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
REPORTED EVENT: AN EVENT REGARDING INACCURATE RESECTION INVOLVING A MAKO TKA SOFTWARE WAS REPORTED. THE EVENT WAS NOT CONFIRMED BECAUSE THE PRODUCT WAS NOT AVAILABLE FOR INSPECTION. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: REVIEW OF THE CASE SESSION FILES WAS NOT PERFORM
| 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 |