Adverse-event reports (MAUDE)
Read this first: MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.
No adverse-event reports are linked to this device.
Recall history
| Initiated | Recall # | Class | Status | Reason | Quantity | Link basis |
|---|---|---|---|---|---|---|
| 2021-09-22 | Z-0118-2022 | Class I | Open, Classified | The firm has become aware of a software anomaly affecting ROSA One 3.1 Brain application which led to the inaccurate placement of an electrode during surgery. The firm has received 3 global complaints related to the issue. An incorrect trajectory could result in serious injury or death if undetected during surgery.Distribution: US Nationwide distribution and International Distribution to countries of: Australia, Taiwan, China, Thailand, Japan, India, South Korea, and the Netherlands. | 119 (US); 55 (OUS) | clearance family |
| 2020-01-06 | Z-1151-2020 | Class II | Terminated | Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.Distribution: US Nationwide | 39 units | clearance family |
| 2020-01-06 | Z-1150-2020 | Class II | Terminated | Some cross-sectional images from the image acquisitions of the patients head may not be reconstructed/displayed properly in two and three dimension views when using ROSA Brain software, potentially compromising the surgery planning.Distribution: US Nationwide | 47 units | clearance family |
| 2019-09-10 | Z-0172-2020 | Class I | Terminated | The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.Distribution: Nationwide domestic distribution. Foreign distribution to Australia, France, Switzerland, Taiwan, and Vietnam. | 93 | clearance family |
| 2017-05-01 | Z-0638-2018 | Class II | Terminated | Robot arm being sent to the wrong positionDistribution: Distributed to CA, DC, FL, IL, KY, MA, MN, NC, NY, OH, and PA. | 16 | clearance family |
| 2017-02-27 | Z-1754-2017 | Class II | Terminated | Unapproved change made by the supplier.Distribution: Nationwide Distribution to CA, FL, IL, KY, MA, MN, NC, NY, OH, PA, and District of Columbia. | 16 | clearance family |
| 2016-10-11 | Z-2868-2017 | Class II | Terminated | Complaint of the head holder connector locking up mechanically when tightened.Distribution: Worldwide Distribution - US including CA, FL, MA, MN, NC, NY, OH, PA, DC; Foreign - Australia, and France | 20 units (16 US, 4 OUS) | clearance family |
| 2016-07-29 | Z-0116-2018 | Class II | Terminated | Non-conforming product label.Distribution: OH and PA. | 2 devices | clearance family |
| 2016-07-20 | Z-0167-2018 | Class II | Terminated | Communication errors between ROSANNA BRAIN software, MARIO software and the Stubli CS8C controller.Distribution: Worldwide Distribution - US Nationwide in the states of OH, FL, MA, MN, DC, NC, CA, NY, PA and countries of Australia and France | 18 (14 US and 4 OUS) | clearance family |
Regulatory clearances
- 510(k)K182417Substantially equivalent (SESE) · 2019-02-07clearance family
- 510(k)K172444Substantially equivalent (SESE) · 2018-03-28clearance family
- 510(k)K151359Substantially equivalent (SESE) · 2015-12-18clearance family
Predicate lineage
Cited as predicate by: K182417
Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.
Manufacturer compliance record
| Date | Type | Outcome | Facility | Citations |
|---|---|---|---|---|
| 2022-06-30 | VAI | Voluntary action indicated | Medtech LLC | 1 |
| 2022-06-30 | VAI | Voluntary action indicated | Medtech LLC | 1 |
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