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 Nervous System Injury (2689); Insufficient Information (4580)

Event Date 12/21/2020

Event Type  Injury  

Manufacturer Narrative

The patient with the dehiscent pharyngeal flap was a female and (b)(6).The patient with the mild myopathy was male and 18 years old.Other patient information was not included in the journal entry.) this value reflects the average age of the patients who underwent the odontoid resection as specific patients could not be identified.Sex) this value reflects the majority gender of the patients who underwent the odontoid resection 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 serial number was 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.

Event Description

Iyer, rajiv r., et al.¿endoscopic transnasal/transoral odontoid resection in children: results of a combined neurosurgical and otol aryngological protocolized, institutional approach.¿ journal of neurosurgery: pediatrics, 2021, pp.1¿8., https://doi.Org/10.3171/2020.12.Peds20729.Summary objective: odontogenic ventral brainstem compression can be a source of significant morbidity in patients with craniocervical disease.The most common methods for odontoidectomy are the transoral and endoscopic endonasal routes.In this study, the authors investigated the use of an institutional protocol for endoscopic transnasal/transoral odontoidectomy in the pediatric population.Methods: from 2007 to 2017, a multidisciplinary institutional protocol was developed and refined for the evaluation and treatment of pediatric patients requiring odontoidectomy.Preoperative assessment included airway evaluation, a sleep study (if indicated), discussion of possible tonsillectomy/adenoidectomy, and thorough imaging review by the neurosurgery and otolaryngology teams.Further preoperative anesthesia consultation was obtained for difficult airways.Intraoperatively, adenoidectomy was performed at the discretion of otolaryngology.The odontoidectomy was performed as a combined procedure.Primary posterior pharyngeal closure was performed by the otolaryngologist.The postoperative protocol called for immediate extubation, advancement to a soft diet at 24 hours, and no postoperative antibiotics.Outcome variables included time to extubation, operative time, estimated blood loss, hospital length of stay, and postoperative complications.Results: a total of 13 patients underwent combined endoscopic transoral/transnasal odontoid resection with at least 3 years of follow-up.All patients had stable to improved neurological function in the postoperative setting.All patients were extubated immediately after the procedure.The average operative length was 201 ± 46 minutes, and the average estimated blood loss was 44.6 ± 40.0 ml.Nine of 13 patients underwent simultaneous tonsillectomy and adenoidectomy.The average hospital length of stay was 6.6 ± 5 days.The first patient in the series required revision surgery for removal of a small residual odontoid.One patient experienced pharyngeal flap dehiscence requiring revision.Conclusions: a protocolized, institutional approach for endoscopic transoral/transnasal odontoidectomy is described.The use of a combined, multidisciplinary approach leads to streamlined patient management and favorable outcomes in this complex patient population.Reported events thirteen patients underwent an odontoid resection.A patient with down syndrome had to have reoperation to address a dehiscent pharyngeal flap.The superior aspect of the flap was too cranial, which resulted in a longer rostrocaudal length.The issue was resolved with a repeat closure in the operating room.Another patient with a complex chiari had mild myelopathy, and had to return to the operating room.

• 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: 12863621
• MDR Text Key: 285933342
• Report Number: 3004785967-2021-01315
• 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: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2021

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: 11/18/2021
• Initial Date FDA Received: 11/23/2021
• 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; Required Intervention
• Patient Age: 12 YR
• Patient Sex: Female