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 Vomiting (2144); Dysphasia (2195); Discomfort (2330); Tissue Breakdown (2681); Swelling/ Edema (4577)

Event Date 06/03/2023

Event Type  Injury  

Event Description

Citation: https://doi.Org/10.1186/s13256-023-03958-2 summary: introduction: chordomas are rare, locally aggressive tumors that often occur in the axial spine, especially in the sacrum.The treatment of chordomas located in the upper cervical spine is challenging.En bloc resection is the preferred surgical option for total tumor removal.Case presentation: we report the case of a c2 chordoma in a 47-year-old thai woman.She was treated with a twostage, anterior¿posterior, c2 total spondylectomy with titanium mesh cage reconstruction and radiotherapy.The first stage involved posterior stabilization from the occiput to c5, a total laminectomy, and removal of the posterior rings of the bilateral foramen transversarium to preserve the bilateral vertebral arteries.The second stage comprised a transoral mandibular split with en bloc resection of c2, followed by titanium mesh cage reconstruction and kick-off anterior cervical plating.At the 5 year follow-up, no tumor recurrence was identified on magnetic resonance imaging.The patient had no neurological deficits but still had minor complications from the anterior transoral mandibular split.Conclusions: excellent midterm results were obtained using a transoral mandibular split with reconstruction and posterior spinal fusion from the occiput to the lower cervical spine coupled with adjuvant radiotherapy.We recommend this approach as the treatment of choice for chordoma in the upper cervical spine.Reported event(s): this article was a case study of a 47-year-old female patient.Post-operatively, the patient experienced minimal regurgitation with retained secretions, plus remnant food at the surgical wound.During the follow-up period before the commencement of radiotherapy, there was wound dehiscence.The patient developed a swelling mass in her throat that caused dysphasia and changed her voice.At the 5-year follow-up, the patient still had some minor complications from anterior transoral mandibular split such as mild dysphagia, throat discomfort after meal, and hypernasal voice, but they did not affect her function.

Manufacturer Narrative

G2: this event occurred in thailand, see e1-e3.H3, h6: no products have been returned to medtronic for analysis.Codes b17, c20, and d15 are applicable.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: 18603870
• MDR Text Key: 334025439
• Report Number: 3004785967-2024-00064
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: TH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2024
• Is this an Adverse Event Report?: Yes
• 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: 01/02/2024
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female