MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for STEALTHSTATION S8 PREMIUM SYSTEM 9735665 manufactured by Medtronic Navigation, Inc.
[185121798]
Other relevant device(s) are: product id: sw kit 9735740 stealth s8 spine, serial/lot : n/a. A medtronic representative went to the site to perform a system check out and they found that the system passed all tests. No parts were replaced and the system functioned as intended. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185121799]
Medtronic received information regarding a navigation system being used for a c3-c7 posterior cervical fusion. It was reported that the site was having issues with the navigation system and the drill system. The site was unable to track or see the drill on the navigation system. They tried to verify the drill system with an attachment and the drill system gave a warning to lock. The site was able to verify the instrument, but it was unable to track the spheres on the drill system nor see a model. The site tried different spheres, but they still could not see the instrument. When going back to the instruments screen, the drill toolcard was still visible with a green line underneath indicating it had been verified. The site then brought in other spine instruments and they could see the instruments with no issue. The site grabbed another drill system and re-added the instrument and it went blank right after verifying. There was no patient harm and the procedure had no delay.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1723170-2020-01084 |
| MDR Report Key | 9885875 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Device Manufacturer Date | 2018-09-26 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | STACY RUEMPING |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635260594 |
| Manufacturer G1 | MEDTRONIC NAVIGATION, INC |
| Manufacturer Street | 826 COAL CREEK CIRCLE |
| Manufacturer City | LOUISVILLE CO 80027 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80027 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STEALTHSTATION S8 PREMIUM SYSTEM |
| Generic Name | INSTRUMENT, STEREOTAXIC |
| Product Code | HAW |
| Date Received | 2020-03-26 |
| Model Number | 9735665 |
| Catalog Number | 9735665 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NAVIGATION, INC |
| Manufacturer Address | 826 COAL CREEK CIRCLE LOUISVILLE CO 80027 US 80027 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |