MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number UNK_NAV_SYS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Dysphagia/ Odynophagia (1815)

Event Date 12/29/2023

Event Type  malfunction  

Manufacturer Narrative

A2) patient age is the mean value of patients in the study.A3) patient gender is the majority value of patient in the study.A4) patient weight not available from the site.B3) event date is the online publishing date of the literature article.D4) device lot number, or serial number, unavailable.G4) 510(k) is dependent upon the device model number and therefore, unavailable.H3,h6) no parts have been received by the manufacturer for evaluation.H4) device manufacturing date is dependent on lot number/serial number, therefore, 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.

Event Description

S.Ferri, f.Cacciola, r.Zaccaria, i.Ghetti, a.Curcio, germano, a.F.Neuronavigated retropharyngeal anterior screw fixation of the odontoid for the treatment of c2 type ii fractures: case report.Acta neurochirurgica supplement 135, https://doi.Org/10.1007/978- 3-031-36084-8_43.Introduction: odontoid fractures account for approximately 5¿15% of the lesions of the cervical spine and are more frequently seen in elderly patients.The common injury is the fracture of the odontoid base (type ii, anderson¿d¿alonzo), which causes atlantoaxial instability.Nonsurgical management with immobilization by the use a rigid tutor or halo vest is associ-ated with high morbidity and a significant risk of failure, especially in high-risk populations, such as patients with obesity or other comorbidities.The surgical strategies adopted to date include the anterior fusion approach and the posterior fusion approach [1].Anterior screw fixation pro-vides stability and significant healing rates and preserves odontoid biomechanics to maintain normal neck mobility.Repeated fluoroscopic checks are required to guide the sur-geon toward the correct positioning of the synthesis system.Our experience makes use of the neuronavigation system, by acquiring intraoperative radiological images of the patient in real time, this system reduces the risk of radiation exposure, thus protecting the patient, the surgeon and the operating room staff and improving the accuracy of the instrumentation.The indications for anterior odontoid screw fixation are as follows: age >50 years, a dislocation of the odontoid >5 mm, reducible type ii fracture with the magnetic resonance (mr) integrity of the transverse ligament, or indirectly by calculat-ing the sum of the distances between the lateral masses and c2 (spence¿s rule) [2].Contraindications include the pres-ence of an irreducible fracture, unfavorable anatomical fac-tors such as short neck and barrel chest, a pathological odontoid fracture, or a fracture line with an oblique orientation to the frontal plane (shear forces can stress a misalign-ment during screw anchoring).It is technically difficult or impossible to perform in patients with short necks [3], obese patients, patients with limited mobility in the cervical spine and patients with a pro-nounced kyphosis of the cervical spine [4].The technique is not indicated in cases of cervical spine stenosis, because of the risk of spinal cord injury associated with hyperextending the neck.This procedure allows the mobility of the structural integrity of the odontoid process (osteosynthesis) without sacrificing normal mobility.Reportable events: the patient had an uneventful postoperative period, with the exception of dysphagia (a complication most commonly found in the postoperative period) [6] that spontaneously disappeared in a few hours.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 18913461
• MDR Text Key: 337775041
• Report Number: 1723170-2024-00812
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• 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 Age: 73 YR
• Patient Sex: Female