MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) O-ARM 1000 IMAGING SYSTEM; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number 9733346

Device Problem Imprecision (1307)

Patient Problems Cerebrospinal Fluid Leakage (1772); Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

This was a retrospective review study.No patient demographics were provided other than age of the patients with postoperative complication related to screw malposition, and sex of 2 of those 3 patients.The article refers to medtronic system used as "o-arm navigation", therefore the system filed here is the o-arm imaging system, at the facility that the lead author/initial reporter is associated with.Facility listed is the facility that the lead author has been associated with.If information is provided in the future, a supplemental report will be issued.

Event Description

Literature: use of the airo mobile intraoperative ct system versus the o-arm for transpedicular screw fixation in the thoracic and lumbar spine: a retrospective cohort study of 263 patients pietro scarone, gabriele vincenzo, daniela distefano, filippo del grande, alessandro cianfoni, stefano presilla, michael reinert objective navigation-enabling technology such as 3d-platform (o-arm) or intraoperative mobile ct (ict-airo) systems for use in spinal surgery has considerably improved accuracy over that of traditional fluoroscopy-guided techniques during pedicular screw positioning.In th is study, the authors compared 2 intraoperative imaging systems with navigation, available in their neurosurgical unit, in terms of the accuracy they provided for transpedicular screw fixation in the thoracic and lumbar spine.Methods the authors performed a retrospective analysis of clinical and surgical data of 263 consecutive patients who underwent thoracic and lumbar spine screw placement in the same center.Data on 97 patients who underwent surgery with ict-airo navigation (ict-airo group) and 166 with o-arm navigation (o-arm group) were analyzed.Most patients underwent surgery for a degenerative or traumatic condition that involved thoracic and lumbar pedicle screw fixation using an open or percutaneous technique.The primary endpoint was the proportion of patients with at least 1 screw not correctly positioned according to the last intraoperative image.Secondary endpoints were the proportion of screws that were repositioned during surgery, the proportion of patients with a postoperative complication related to screw malposition, surgical time, and radiation exposure.A blinded radiologist graded screw positions in the last intraoperative image according to the heary classification (grade 1¿3 screws were considered correctly placed).Results a total of 1361 screws placed in 97 patients in the ict-airo group (503 screws) and in 166 in the o-arm group (858 screws) were graded.Of those screws, 3 (0.6%) in the ict-airo group and 4 (0.5%) in the o-arm group were misplaced.No statistically significant difference in final accuracy between these 2 groups or in the subpopulation of patients who underwent percutaneous surgery was found.Three patients in the ict-airo group (3.1%, 95% ci 0%¿6.9%) and 3 in the o-arm group (1.8%, 95% ci 0%¿4.0%) had a misplaced screw (heary grade 4 or 5).Seven (1.4%) screws in the ict-airo group and 37 (4.3%) in the o-arm group were repositioned intraoperatively (p = 0.003).One patient in the ict-airo group and 2 in the o-arm group experienced postoperative neurological deficits related to hardware malposition.The mean surgical times in both groups were similar (276 [ict-airo] and 279 [o-arm] minutes).The mean exposure to radiation in the ict-airo group was significantly lower than that in the o-arm group (15.82 vs 19.12 msv, respectively; p = 0.02).Conclusions introduction of a mobile ct scanner reduced the rate of screw repositioning, which enhanced patient safety and diminished radiation exposure for patients, but it did not improve overall accuracy compared to that of a mobile 3d platform.Adverse events: there were 4 misplaced screws in 3 patients in the o-arm group 37 screws were repositioned during surgery in the o-arm group 2 patients in the o-arm group experienced postoperative neurological deficits related to hardware malposition: 1.A 57-year-old patient with an l1 fracture after positioning of a jamshidi needle to prepare the trajectory for a t11 right percutaneous screw suffered major bleeding, which was stopped using a hemostatic agent.Surgery was completed without screw positioning on the t11 pedicle.The patient experienced major perfusion problems in both limbs immediately after the procedure.A thoracic ct angiogram revealed a thrombus in the aorta, probably as a result of migration of the hemostatic agent in the segmental vessel at t11.A thoracotomy was performed, and the thrombus was removed, which resulted in complete clinical recovery.On the final ct scan, this patient¿s screws were all classified as heary grade 1.This major complication was related to an accuracy error, because the needle positioning appeared to be correct on the screen, but the real position was lateral to the vertebral body.2.In the second case, a postoperative right foot drop (m2) developed after incorrect positioning of a jamshidi needle at the right t11 level with csf leakage after entrance in a (b)(6) woman treated for a t12 fracture with a posterior percutaneous fixation from t11 to l1.The jamshidi needle was repositioned under o-arm fluoroscopic control.In the final ct scan, the t-11 screws in this patient were judged to be heary grade 1.These inaccuracies of the navigation.

• Brand Name: O-ARM 1000 IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC (LITTLETON); 300 foster st; littleton MA 01460
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9285372
• MDR Text Key: 172687030
• Report Number: 3004785967-2019-01935
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K050996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733346
• Device Catalogue Number: 9733346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention