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); Hematoma (1884); Unspecified Infection (1930); Muscle Weakness (1967); Dysphasia (2195); Cognitive Changes (2551); Syncope/Fainting (4411); Insufficient Information (4580)

Event Date 02/21/2022

Event Type  Injury  

Event Description

Nie, j.Z., weber, m.W., revelt, n.J., nordmann, n.J., watson, v.L., nie, j.W., menezes, s.A., delfino, k., cozzens, j.W., espinosa, j.A., amin, d., <(>&<)>amp; acakpo-satchivi, l.(2022).Comparison of using intraoperative computed tomography¿based 3-dimensional navigation and fluoroscopy in anterior cervical diskectomy and fusion for cervical spondylosis.World neurosurgery, 161.Htt ps://doi.Org/10.1016/j.Wneu.2022.02.089 summary: objective: anterior cervical diskectomy and fusion (acdf) is a highly successful procedure to treat spinal cord or nerve root compression; however, complications can still occur.With advancements in imaging, 3-dimensional (3d) reconstruction allows real-time instrument tracking in a surgical field relative to the patient¿s anatomy.Here, we compare plate positioning and short-term outcomes when using 3d navigation to fluoroscopy in acdf for degenerative spine disease.Methods: all acdfs for cervical spondylosis performed by 6 surgeons at a single center between 2010 and 2018 were included.Acdfs were divided into those performed using 3d navigation or fluoroscopy.Records were assessed for patient demographics, american society of anesthesiology score, number of operated interspaces, operative time, length of stay, perioperative complications, and 90-day readmissions.Postoperative images were reviewed for lateral and angular plate deviations.Results: a total of 193 acdfs performed with 3d navigation and 728 performed with fluoroscopy were included.After controlling for d emographics and surgical characteristics, using 3d navigation was associated with less lateral plate deviation (p [ 0.048) and longer operative times per interspace (p <(><<)> 0.001) but was not associated with angular plate deviation (p [ 0.724), length of stay (p [ 0.393), perioperative complications (p [ 0.844), and 90-day readmissions (p [ 0.539).Conclusions: using 3d navigation in acdf for degenerative disease is associated with slightly more midline plate positioning and comparable short-term outcomes as using fluoroscopy and can be a suitable alternative.Advantages of using this technology, such as improved visualization of anatomy, should be weighed against disadvantages, such as increased operative time, on a per-patient basis.Reported event: one hundred and ninety-three patients with ahistology of spinal cord or nerve root compression underwent anterior cervical diskectomy and fusion (acdf).Perioperatively, nine patients had dysphagia and/or dysphonia.Post-operatively, issues developed causing patients to be readmitted within 90 days of the procedure.There was one case of hematoma, one infection( not located on the surgical site), two cases of weakness, syncope, and/or unsteadiness, one pulmonary problem, and one psychiatric problem.

Manufacturer Narrative

Patient information was not included in the journal entry.Age or date of birth: this value reflects the mean age of the patients who underwent the anterior cervical diskectomy and fusion as specific patients could not be identified.Sex: this value reflects the majority gender of the patients who underwent the anterior cervical diskectomy and fusion as specific patients could not be identified.The article did not provide the date of the procedure.The event date provided is the accepted date.The article citation is included.The system product number and serial number were not provided in the journal article.Udi not available for this system.No 510k provided as system is unknown.No evaluation was performed as the event was reported as a literature article.Device manufacturing date is unavailable.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: 14982154
• MDR Text Key: 295679496
• Report Number: 3004785967-2022-00453
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2022

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: 07/06/2022
• Initial Date FDA Received: 07/11/2022
• 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): Other
• Patient Age: 60 YR
• Patient Sex: Female