MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-26 for BASE SYS BI70002000 O-ARM SYS O2 manufactured by Sanmina -sci Systems.
[186731946]
Onsite functional and visual examination was performed by a manufacturer representative. The system passed a system checkout and was determined to be operational. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186731947]
Medtronic received information regarding an imaging device being used for a sacroiliac and thoracolumbar procedure. It was reported fixation of the screw was performed using navigation, but there was a deviation of the screw towards the spinal cord was confirmed on the post-operative confirmation. It seemed that the error was about 2 cm. The operation was completed by switching to a c-arm. It was reported that there was a high possibility that it was not a deviation of the screw caused by the imaging system, but due to the inaccuracy of the navigation there was suspicion of a spinal cord injury. There was no other information reported about the impact of the patient due to japanese privacy laws. There was an unknown reported delay to procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006544299-2020-00104 |
| MDR Report Key | 9883915 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| 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 | 2019-01-21 |
| 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 | SANMINA -SCI SYSTEMS |
| Manufacturer Street | KM 15.5 NO. 29, PLANT 06 |
| Manufacturer City | CARR. CHAPALA-GUADALAJARA,JAL 45640 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 45640 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BASE SYS BI70002000 O-ARM SYS O2 |
| Generic Name | INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM |
| Product Code | OWB |
| Date Received | 2020-03-26 |
| Model Number | BI70002000 |
| Catalog Number | BI70002000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SANMINA -SCI SYSTEMS |
| Manufacturer Address | KM 15.5 NO. 29, PLANT 06 CARR. CHAPALA-GUADALAJARA,JAL 45640 MX 45640 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-26 |