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 Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Bacterial Infection (1735); Dysphagia/ Odynophagia (1815); Unspecified Infection (1930); Unspecified Tissue Injury (4559)

Event Date 12/25/2023

Event Type  Injury  

Manufacturer Narrative

A1-a5) patient information was unavailable from the site.B3) event date is the online publishing date of the literature article.D4) device lot number, or serial number, unavailable.G4) 510(k) is dependent upon the device model number and therefore, unavailable.H3,h6) no parts have been received by the manufacturer for evaluation.H4) device manufacturing date is dependent on lot number/serial number, therefore, unavailable.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.

Event Description

Wada, k., mori, s., shimamoto, s., inoue, t., tamaki, r., okazaki, k.Surgical outcomes of intraoperative o-arm versus c-arm fluoroscopy in occipitocervical fixation: a retrospective analysis.British journal of neurosurgery.Doi: 10.1080/02688697.2023.2297879 abstract purpose: this study aims to compare the effect of using o-arm and c-arm fluoroscopy on the surgical outcomes of occipitocervical fixation.Methods: the study included patients who underwent occipitocervical fixation using o-arm or c-arm between 2005 and 2021.Of 56 patients, 34 underwent o-arm-assisted surgery (o-group) and 22 underwent c-arm-assisted surgery (c-group).We assessed surgical outcomes, including operative time, intraoperative blood loss, perioperative complications, and bone union.Results: almost half of the patients had rheumatoid arthritis-related disorders in both groups.Sixteen cases (47.1%) in the o-group and 12 cases (54.5%) in the c-group were fixed from occipito (oc) to c3, 12 cases (38.2%) in the o-group and 7 cases (31.8%) in the c-group from oc to c4-7, 5 cases (14.7%) in the o-group, and 3 cases (13.6%) in the c-group from oc to t2 (p¼0.929).There was no significant difference in operative time (p¼0.239) and intraoperative blood loss (p¼0.595) between the two groups.Dysphagia was the most common complication in both groups (o-group vs.C-group, 11.7% vs.9.1%).Regarding implant-related complications, occipital plate dislodgement was observed in four cases (18.2%) in the cgroup (p¼0.02).The bone union rate was 96.3% in the o-group and 93.3% in the c-group (p¼1).Conclusions: o-arm use is associated with a reduced rate of occipital plate dislodgment and has a similar complication incidence compared with c-arm-assisted surgery and does not prolong operative time despite the time needed for setting and scanning.Accordingly, an o-arm is safe and useful for occipitocervical fixation surgery.Reported events: one case had reoperation dysphagia was the most frequent complication in both groups four cases with the oarm two cases were due to poor alignment implant-related complications were observed in five cases (8.9%) other complications such as surgical site infection with 2 cases in the oarm in a patient in the o- group four years after surgery, rod breakage was noted pneumonia occurred in 1 case duodenal ulcer occurred in 1 case see attached literature article.

• 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: 18837052
• MDR Text Key: 336959548
• Report Number: 3004785967-2024-00140
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2024

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: 02/21/2024
• Initial Date FDA Received: 03/05/2024
• 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