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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

A1-a5) patient information was not included in the journal entry a2) this value reflects the mean age of the patients who underwent the screw placement procedure as specific patients could not be identified.A3) this value reflects the majority gender of the patients who screw placement procedure as specific patients could not be identified.B3) the article did not provide the date of the procedure.The event date provided is the accepted date.B5) the article citation is included.D4) the system product number and serial number were not provided in the journal article.Udi not available for this system.G2) no 510k provided as system is unknown.H3) no evaluation was performed as the event was reported as a literature article.H4) device manufacturing date is 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

Citation: li, c.-m., zhao, s.-j., xu, j.-z., li, q., quan, r.-f., <(>&<)> deng, x.-m.(2023).Case series: o-arm navigation assisted by the wiltse approach improves the accuracy of pedicle screw placement in ankylosing spondylitis combined with thoracolumbar fractures.Medicine, 102(52).Https://doi.Org/10.1097/md.0000000000036807 abstract: here we assessed the accuracy of o-arm navigation assisted by wiltse approach to improve based pedicle screw insertion in ankylosing spondylitis combined with thoracolumbar fractures.We then compared it with the freehand pedicle screw insertion technique.The study sample included 32 patients with ankylosing spondylitis combined with thoracolumbar fractures.Pedicle screw reduction and internal fixation was performed under an o-arm navigation system assisted by a wiltse approach-combined osteotomy (¿navigation group,¿ n = 17) and posterior pedicle screw reduction and internal fixation was performed using freehand technique combined osteotomy (¿freehand group,¿ n = 15).We then compared the operation time and bleeding volume between the 2 groups.The visual analog scale (vas) and oswestry disability index (odi) were then used to evaluate the clinical efficacy and the kyphosis cobb angle was used to evaluate the radiological efficacy before operation, 3 days after operation and after the last follow-up.All complications were noted when detected.Finally, classification of screw positions as proposed by neo et al was used to evaluate the relationship of the position between the screw, the bone cortex, and the incidence of screw penetration.All patients were followed up for 18 to 36 months (i.E., 24.2 ± 3.5 months).The operation time and intraoperative bleeding volume of the navigation group were significantly shorter (lower) than those of the freehand group (p <(><<)>.05).In addition, both groups showed significantly decreased vas, odi, and cobb angle 3 d ays after the operation and at the last follow-up when compared to values recorded pre-operation.However, we found no significant difference in vas, odi, and cobb angle between the 2 groups (p >.05).We identified no complications (e.G., infection, vte/pe, or nerve injury).Moreover, the pedicle screw placement position of the navigation group was better than that of the freehand group (p <(><<)>.05), and the screw cortical penetration rate was lower than the freehand group (p <(><<)>.05).During the process of posterior pedicle screw placement, o-arm navigation assisted by the wiltse approach can significantly reduce operation time, minimize the amount of bleeding volume, and enhance the accuracy of pedicle screw implantation.Reported event: 1.Seventeen patients with a history of ankylosing spondylitis (as) underwent a screw placement procedure using the medtronic imaging system.Three out of two-hundred and eight screws were considered neo grade 1.2.Out of 32 patients, 17 required a readjustment of screw position after the initial screw placement.

• 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: 18876119
• MDR Text Key: 337863763
• Report Number: 3004785967-2024-00154
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 03/11/2024
• 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 Age: 49 YR
• Patient Sex: Male