S3 · 06/2021 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 06/2021 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2021-00107 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
REPORTED EVENT: THE MPS REPORTED SURGEON REQUEST FOR SERVICE VISIT DUE TO INACCURATE CUTS DURING TKA CASE. MPS REPORTED THAT DOCTOR SAID THE CUTS FELT OFF IN TKA CASE AND THAT ANTERIOR CUT NOTCHED EVEN THOUGH IT SHOULD HAVE HAD ENOUGH FLEXION NOT TO. A COUPLE MONTHS AGO THIS SAME
| 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 |