FDA.reportPublic FDA data

MAUDE MDR 9883915

MDR report key
9883915
Report number
3006544299-2020-00104
Event key
0
Event type
3
Date of event
2020-03-04
Date received
2020-03-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
STACY RUEMPING
Address
7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BASE SYS BI70002000 O-ARM SYS O2INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEMSANMINA -SCI SYSTEMSOWBBI70002000BI70002000Y N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2601. O; 2. R

Event Narratives#

N

Patient 1

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.

D

Patient 1

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.