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

Model Number UNK_OARM_SYS

Device Problem Imprecision (1307)

Patient Problem Tissue Damage (2104)

Event Date 12/08/2019

Event Type  Injury  

Manufacturer Narrative

Patient age not available from the site.Patient gender is the majority value of patients in the study.Patient weight not available from the site.Event date is the accepted date of the publication.Device lot number, or serial number, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: kh.Mukhametzhanov, d.Zh.Mukhametzhanov, b.M.Karibaev, sh.A.Bulekbaev, o.S.Bekarisov1, usainova, n.N.Dyusenbaev.Using an intra-operative computed tomography scanner with a navigation station for spinal surgery.Electron j gen med 2019;16(6):em182 https://doi.Org.10.29333/ejgm/115859.Abstract: the authors conducted a retrospective and prospective analysis of the results of 350 operations using the eic, 390 operations with o arm and 11 operations with o arm and the stealth-station navigation station (medtronic, usa).To the 350 patients operated on using the eic, 1822 screws were implanted, on average 5.2 screws per operation.117 (6.5%) screws were implanted incorrectly, of which a permissible or clinically insignificant malposition of the screw was noted in 90 (4.9%) patients.Incorrectly installed screws remaining in 27 (1.5%) patients required revision surgery.To 390 patients operated with o arm, 2477 screws were implanted, on average 6.3 screws during one operation.Incorrectly 33 (1.3%) screws were implanted, of which 25 screws were acceptable malposition.Invalid malposition of 8 (0.3%) screws was eliminated during the current operation.Comparing trials of the total number of incorrectly implanted screws during operations using the eic and o arm showed that they were more often observed when using the eic (p <(><<)>0.001) and there was no unacceptable malposition of the screws when performing the operation under o arm, since it was diagnosed in time during current operation and eliminated.A total of 66 screws were implanted in 11 patients operated using o arm and the stealth-station navigation station, an average of 6 screws during one operation.Inaccurate implantation of screws was not observed in any patient.O-arm with the stealth-station navigation station is the most modern method of controlling the correctness of spinal operations when anatomical landmarks are partially invisible - with open operations or invisible at all - with minimally invasive surgical interventions in real time.Reported event: 33 incorrectly positioned screws were placed in procedures using the o-arm with the eic group.25 were left in place and 8 were revised.

• Brand Name: MEDTRONIC NAVIGATION
• 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10751683
• MDR Text Key: 213693330
• Report Number: 3004785967-2020-01289
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: KZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2020

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: UNK_OARM_SYS
• Device Catalogue Number: UNK_OARM_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2020
• Initial Date FDA Received: 10/28/2020
• 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