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 Dysphagia/ Odynophagia (1815); Paralysis (1997); Insufficient Information (4580)

Event Date 06/07/2023

Event Type  Injury  

Event Description

Citation: zhang, b., qi, g., han, d., shi, j., sun, j.(2023).Significance of o-arm assisted anterior controllable antedisplacement and fusion surgery in treatment of cervical ossification of posterior longitudinal ligament.World neurosurgery.Https://doi.Org/10.1016/j.Wneu.2023.06.023.Summary: background: anterior controllable antedisplacement and fusion (acaf) surgery for cervical opll is commonly used in clinical practice and has shown promising results.Nonetheless, precise slotting and lifting are the most critical procedures in acaf surgery to avoid several unique and dangerous problems, such as residual ossification and incomplete lifting.C-arm intraoperative imaging can help with traditional cervical surgery but not with the precise slotting and lifting operation in acaf surgery.Methods: fifty-five patients admitted to our department with cervical opll were retrospectively enrolled.Given the selection of intraoperative imaging technique, patients were divided into the c-arm group and o-arm group.The operation time, intraoperative blood loss, hospital stay, japanese orthopaedic association score, oswestry disability index score, visual analog scale score, slotting grade, lifting grade, and complications were recorded and analyzed.Results: at the final follow-up, all patients acquired satisfactory improvement of neurologic function.Patients in the o-arm group, on the other hand, had a better neurologic state 6 months after surgery and at the final follow-up than those in the c-arm group.Furthermore, slotting and lifting grade were considerably higher in the o-arm group than in the c-arm group.No severe complications were encountered in both groups.Conclusions: o-arm assisted acaf can achieve accurate slotting and lifting, which might effectively reduce the occurrence of complications and is worthy of clinical application.Reported event: 1.Twenty-nine patients with a history of ossification of posterior longitudinal ligament (opll) underwent anterior controllable an tedisplacement and fusion (acaf) surgery using the imaging system.Four patients ended up with residual ossification.2.Twenty-nine patients with a history of opll underwent acaf surgery using the imaging system.Four patients ended up with residual ossification.Two patients experienced incomplete lifting.3.Twenty-nine patients with a history of opll underwent acaf surgery using the imaging system.Four patients ended up with residual ossification.One patient had c5 nerve palsy.Twenty-nine patients with a history of opll underwent acaf surgery using the imaging system.Four patients ended up with residual ossification.Two patients had dysphagia.

Manufacturer Narrative

A1,a4) select patient information cannot be provided due to regional privacy regulations.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.A3) this value reflects the majority gender 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 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.

Manufacturer Narrative

Correction: a2) this value reflects the mean age of the patients who underwent the anterior controllable anti-displacementandand fusion as specific patients could not be identified.A3) this value reflects the majority gender of the patients who underwent the anterior controllable anti-displacementand fusion as s pecific 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: 17470634
• MDR Text Key: 320506326
• Report Number: 3004785967-2023-00478
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

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: 07/31/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA 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 Outcome(s): Other
• Patient Age: 52 YR
• Patient Sex: Male