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 Problems Post Operative Wound Infection (2446); Unspecified Tissue Injury (4559)

Event Date 11/04/2020

Event Type  Injury  

Manufacturer Narrative

Patient information was unavailable from the site.Event date is the accepted date of the publication.Device lot number, or serial number, unavailable.510(k) unavailable as the value is dependent upon the product number.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.Concomitant medical products: other relevant device(s) are: product id: unk_nav_sys, serial/lot #: unk.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: mohammed banat, johannes wach, abduallah salemdawod, majd bahna, jasmin scorzin, hartmut vatter.The role of intraoperative image guidance systems (three-dimensional c-arm versus o-arm) in spinal surgery: results of a single-center study.World neurosurgery.2020.Https://doi.Org/10.1016/j.Wneu.2020.11.013 -objective: spinal dorsal instrumentation is an established treatment option for many spinal disorders, including degenerative diseases, trauma, infection, and neoplasia.Combined with navigation, intraoperative fluoroscopy reduces the risk of incorrect screw plac ement.This study aimed to evaluate the efficacy and validity of fluoroscopy (intraoperative navigation with threedimensional rotation of c-arm vs.O-arm) for placing screws and verifying placement during spinal surgery compared with postoperative control computed tomography (ct) scans.- methods: this retrospective single-center study included 240 patients operated on between july 2017 and april 2020.Intraoperative images were acquired using an arcadis orbic 3d c-arm with a dedicated navigation system or o-arm with a dedicated navigation system.Postoperative surgical complications, including neurological deficits, wound healing disorder, and need for revision, were assessed.Final screw position was verified by postoperative ct.Finally, mismatches between intraoperative and postoperative ct results were compared using the rampersaud grade (aed).- results: the evaluation included 1614 screws: 94 patients in the c-arm group (cag) and 146 patients in the o-arm group (oag).After implantations, a second ct scan was performed intraoperatively.In cag, 3% (n [ 20) of the screws had to be replaced directly owing to inadequate positioning with median or lateral breaches, and 3.5% of screws in oag (n [ 35) showed median or lateral projections.Rampersaud grade a was achieved in 85.7% of screws in cag and 87.4% in oag.Grade b was achieved in 11.5% of screws in cag and 11.9% in oag.Grade c was achieved in 2.5% of screws in cag and 0.7% in oag.Grade d was achieved in 0.3% of screws in cag and none of the screws in oag.-conclusions: our data show that placement of screws using intraoperative imaging in combination with a navigation tool is accurate.Navigation coupled with the o-arm had significant advantages in accuracy over navigation with three-dimensional c-arm fluoroscopy.However, both systems offer a high level of accuracy.Reported event(s) -120 screws were placed with a grade b wall breach -7 screws were placed with a grade c wall breach -5 patients were reported to have had wound infections.Additional information was received.It was reported that the complications were independent from the navigation system products and expected post-operative complications.

• 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: 11049698
• MDR Text Key: 223608421
• Report Number: 3004785967-2020-01539
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/21/2020

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: 12/04/2020
• Initial Date FDA Received: 12/21/2020
• 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