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 06/06/2023

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 anterior cervical diskectomy and fusion as specific patients could not be identified.B3) the article did not provide the date of the procedure.The event date provided is the published 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.Digital sharing of the article would be in violation of copyright permission.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: degulmadi, d., dave, b.R., chauhan, v., krishnan, a., mayi, s.C., rai, r., dave, m.B., bali, s., charde, p., <(>&<)> anil, a.(2023).Comparative study on accuracy of intra-operative computed tomography-navigation based pedicle screw placement with skin vs bone fixed dynamic reference frame in minimally invasive transforaminal lumbar interbody fusion.Global spine journal, 219256822311818.Https://doi.Org/10.1177/21925682231181884.Summary: objective: to compare the accuracy of intra-operative navigation-assisted percutaneous pedicle screw insertion between bone fixed and skin fixed dynamic reference frame (drf) in minimally invasive transforaminal lumbar interbody fusion (mis-tlif).Methods: between october 2018 and september 2022, patients who underwent mis-tlif were included in this study with drf fixed either on bone (group b) or skin (group s).Pedicle screws were inserted under the guidance of intra-operative cone beam computed tomography (cbct) based navigation.Accuracy of pedicle screw placement was immediately checked by a final intra-operative cbct spin.Results: among 170 patients, group b included 91 patients and group s included 79 patients.Out of total 680 screws, 364 screws (group b)and 316 screws (group s) were placed.Patient's demographic data and distribution of screws showed no statistically significant difference.The accuracy showed no significant difference between both the groups (94.5% in group b and 94.3% in group s).Conclusions: skin fixed drf can serve as an alternate way for placement and avoids extra incision with similar accuracy in pedicle screw insertions with bone fixed drf using intra-operative ct guided navigation in mis tlif.Reported event: 1.One hundred and seventy patients underwent a minimally invasive transforaminal lumbar interbody fusion (mis-tlif) procedure.Twenty screws that were placed with the bone fixed drf group were considered grade 1.2.One hundred and seventy patients underwent a (mis-tlif) procedure.Sixteen screws that were placed with the skin fixed drf group were considered grade 1.3.One hundred and seventy patients underwent a (mis-tlif) procedure.Two screws that were placed with the skin fixed drf group were considered grade 2.

Manufacturer Narrative

This value reflects the mean age of the patients who underwent the minimally invasive transforaminal lumbar interbody fusion (mis-tlif) as specific patients could not be identified.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: 17469887
• MDR Text Key: 321473132
• Report Number: 3004785967-2023-00477
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• 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: 08/08/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 48 YR