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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Skin Tears (2516); Unspecified Tissue Injury (4559)

Event Date 03/28/2022

Event Type  Injury  

Event Description

Citation: ran harel, gil kimchi, avital perry nachshon knoller (2022): c1 lateral mass screw insertion using cannulated, navigated screws: preliminary results of a novel technique, british journal of neurosurgery, doi: 10.1080/02688697.2022.2054948 summary: purpose: the upper cervical spine region is densely populated by neural and vascular structures impeding the approach for fusion surgery.Technological advancement simplify the approach to c1-c2 fusion, thus reduce risks.The current paper purpose is to describe initial experience with a novel technique modification for c1 lateral screw insertion that incorporates cannulated-navigated screw system with intra-operative 3d imaging.Methods: a single-center single surgeon database was reviewed to identify all patients who underwent placement of c1 lateral mass screw insertion using the novel technique modification described below, on 2020.This cohort was retrospectively analyzed and compared with a cohort of patients who were operated on by the same surgeon with non-cannulated, navigated screws with intra-operative 3d imaging (o-arm, medtronic, usa) between 2011 and 2019.Following navigated starting hole and drilling of the c1 lateral mass, a blunt guide-wire is used to palpate the hole and cannulated screw is advanced to the correct position over the wire.After initial purchase, a navigated screw driver is used for final screw depth position.Results: twelve c1 lateral mass screws were inserted in six patients using this novel cannulated-navigated screw placement technique and compared to 24 patients operated using navigated non-cannulated screws.Minimal estimated blood loss (ebl) was recorded in five of six cases undergoing the novel cannulated navigated placement of c1 lateral mass screws.Comparison to non-cannulated cohort demonstrated an ebl of 83cc vs.354cc (not significant).Mean surgery time was 97min and 118min for the cannulated-navigated and navigated only procedures (p¼0.03, statistically significant) respectively.In the current cohort, all screws were rated in optimal position and no repositioning procedures were performed.Conclusion: the new method presented allows for faster and possibly safer and more accurate c1 lateral mass screw insertion.Reported events: this article documented a retrospective study with a study group and a control group.There were 6 patients in the study group, 5 males and 1 female.The a mean age was 48 years.There were 24 patients in the control group, 14 males and 10 females.The mean age was 50 years.In the study group, one inadvertent dural tear was identified.In the control group, there was one wound infection requiring surgical revision and one csf leak.

Manufacturer Narrative

G2: this event occurred in israel, 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.

• 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: 17509517
• MDR Text Key: 321044233
• Report Number: 3004785967-2023-00496
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 08/11/2023

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?: No
• 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: 08/07/2023
• Initial Date FDA Received: 08/11/2023
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Male