S3 · 07/2024 · Stryker Mako
| Company | Stryker Mako |
| Category | medical robotics |
| Type | injury |
| Date | 07/2024 |
| Time of day | not documented |
| Location | no physical site (recall / fleet-wide / aggregate record) |
| Severity | S3 (recall, enforcement, or fleet-wide fault) |
| Scale | MDR 3005985723-2024-00092 |
| Confidence | medium |
| Verification | Yes - adversarially checked against the cited source |
| Source | openFDA MAUDE |
THIS PI IS FOR THE INITIAL CASE ON 21/JUNE/2024. ON FRIDAY 6/21 THERE WAS A RTHA 4.1 AND THE CUP ENDED UP ALMOST VERTICAL, I WOULD ESTIMATE 60-70 DEGREES OF INCLINATION. I WAS NOT IN THE CASE, BUT FROM WHAT I WAS TOLD BOTH THE ROBOT AND THE BONE WERE RE-REGISTERED. THIS EVENTUALL
| 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 |