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 Impaired Healing (2378); Unspecified Tissue Injury (4559)

Event Date 04/14/2023

Event Type  Injury  

Event Description

Anton, g.Alsalahi, a., yoon, e.J., turnbull, j., dragonette, j., richards, b., tong, d., soo, t.M.Fusion and patient-reported outcomes after navigated decortication and direct arthrodesis in minimally invasive sacroiliac joint fusion using cylindrical threaded implants: a case series and literature review.Neurosurgery focus.2023.55 (1):e2.Doi: 10.3171/2023.4.Focus23249 objective sacroiliac joint (sij) dysfunction is a significant cause of back pain.Despite recent advances in minimally invasive (mis) sij fusion, the fusion rate remains controversial.This study sought to demonstrate that a navigated decortication and direct arthrodesis technique in mis sij fusion would result in satisfactory fusion rates and patient-reported outcomes (pros).Methods the authors retrospectively reviewed consecutive patients who underwent mis sij fusion from 2018 to 2021.Sij fusion was performed using cylindrical threaded implants and sij decortication employing the o-arm surgical imaging system and stealthstation.The primary outcome was fusion, evaluated using ct at 6, 9, and 12 months post­operatively.Secondary outcomes included revision surgery, time to revision surgery, visual analog scale (vas) score for back pain, and the oswestry disability index (odi), measured preoperatively and 6 and 12 months postoperatively.Patient demographics and perioperative data were also collected.Pros over time were analyzed using anova followed by a post hoc analysis.Results one hundred eighteen patients were included in this study.The mean (± sd) patient age was 58.56 ± 13.12 years, and most patients were female (68.6% vs 31.4% male).There were 19 smokers (16.1%) with an average bmi of 29.92 ± 6.73.One hundred twelve patients (94.9%) underwent successful fusion on ct.The odi improved signifi­cantly from baseline to 6 months (117.73, 95% cl 2.43-13.03, p = 0.002) and from baseline to 12 months (117.54, 95% cl 1.65-13.43, p = 0.008).Similarly, vas back pain scores improved significantly from baseline to 6 months (/12.31, 95% cl 1.07-3.56, p <(><<)> 0.001) and from baseline to 12 months (111.63, 95% cl 0.25-3.00, p = 0.015).Conclusions mis sij fusion with navigated decortication and direct arthrodesis was associated with a high fusion rate and significant improvement in disability and pain scores.Further prospective studies examining this technique are warranted.Reported events: two patients (1.7%) underwent subsequent revision sij fusion with a median of 10 months to the revision date (rang; 9-11 months).Both patients underwent revision due to pseudarthrosis and recurrent symptoms.

Manufacturer Narrative

A2) patient age is the mean value of patients in the study.A3) patient gender is the majority value of patient in the study.A4) patient weight not available from the site.B3) event date is the online accepted 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.

• 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: 17602803
• MDR Text Key: 321730958
• Report Number: 3004785967-2023-00511
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/23/2023

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: 08/02/2023
• Initial Date FDA Received: 08/23/2023
• 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
• Patient Age: 59 YR
• Patient Sex: Female