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

Model Number UNK_OARM_SYS

Device Problem Imprecision (1307)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

Citation: sagepub.Com/journals-permissions doi: 10.1177/21925682231166108 summary: introduction:: cervical pedicle screws (cps) are biomechanically superior to other spinal fixation anchors; however, placement is te chnically demanding, and screw malposition could have catastrophic consequences.Computer navigation has been shown to improve accuracy rates in thoracolumbar pedicle screw placement.However, there are limited studies on use of navigation for placing cps.We report accuracy rates of computer navigated (cn) cps placement in a single institution.Materials and methods: between january 2014 and march 2020, we identified 100 patients who underwent cn cps placement (c3-c7) and with either postoperative computed tomography (ct) or intraoperative o-arm 3d scan for screw evaluation.Screw position was evaluated in axial, coronal and sagittal planes, and graded as follows (figure 1): 0 ¿ fully in bone; i ¿minor breach deemed inconsequential (<(><<)> 25%of screw width); ii ¿ breach that is considered not ideal, but acceptable (25-50% of screw width); iii ¿ breach that is considered either dangerous or compromising strength of fixation.Screws that were >50% outside the pedicle in any direction were considered grade iii.Results: 413 cn cps screws (c3-c7) were placed in 100 patients (54m:46f), with a mean age of 56 years (range 10- 81).Number of fusion levels ranged from 1 to 12.44 patients had previous cervical spine fusion (29 anterior; 15 posterior).12 patients underwent proximal extension of previous thoracolumbar fusion.Rates of serious screw malpositions: gr iii = 15/413 (3.6%), combined gr ii/iii = 42/413 (10.2%).A breakdown of gr iii screws per level: c3 = 1/33 (3.0%), c4 = 3/ 63 (4.8%), c5 = 3/72 (4.2%), c6 = 5/85 (5.9%), c7 = 3/160 (1.9%).Breaking down the combined gr ii/iii screws per level: c3 = 8/33 (24.2%), c4 = 9/63 (14.3%), c5 = 8/72 (11.1%), c6 = 10/85 (11.8%), c7 = 7/160 (4.4%).Mean screw grade per level: c3 = 0.88; c4 = 0.67; c5 = 0.51; c6 = 0.46; c7 = 0.26.Using non-parametric ranksum tests with bonferroni correction, significant differences were noted between the following: c3 vs each of the two most caudal levels (c6 and c7; p = 0.029 and <(><<)>0.001 respectively); and c7 vs each of the upper 2 levels (c3 and c4; p = 0.029 and <(><<)>0.001, respectively).Conclusion: our study shows a 3.6% rate of dangerous/unacceptable (gr iii) screw placement, and 10.2% non-optimal (combined gr ii and iii) using intraoperative 3d imaging and computer navigation.Mean screw grade incrementally decreased in a cephalad to caudad direction (c3 to c7), indicating that pedicle breach is more likely at the upper subaxial cervical levels.This also confirms that c7 is the safest level for cps placement.Our results add to only few other studies that have reported on this technique.To our knowledge this is the biggest study on a uniform technique of navigated pedicle screw placement that included only subaxial levels c3-c7.Reported event(s): there was a 3.6% rate of dangerous/unacceptable (gr iii) screw placement, and 10.2% non-optimal (combined gr ii and iii) using intra operative 3d imaging and computer navigation.

Manufacturer Narrative

H3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: O-ARM IMAGING SYSTEM
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 17564095
• MDR Text Key: 321334084
• Report Number: 3004785967-2023-00505
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 08/04/2023
• 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 Age: 56 YR
• Patient Sex: Male