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 Problems Bone Fracture(s) (1870); Numbness (2415); Unspecified Tissue Injury (4559)

Event Date 09/05/2022

Event Type  Injury  

Event Description

Gurel, r., amzallag, n., benady, a., efrima, b., barriga, j., gortzak, y., sternheim, a., dadia, s., hasbani, n., segal, o.Intraoperative three-dimensional navigation for surgical treatment of osteoid osteoma in the foot and ankle ¿ a series of 14 cases.Foot and ankle surgery.2022.28 (1468¿1472) https://doi.Org/10.1016/j.Fas.2022.09.001 background: the surgical treatment for osteoid osteoma (oo) in the foot and ankle is challenging.It is difficult to locate the lesion and the anatomy is crowded by sensitive structures.The purpose of this study was to describe the outcomes of navigated mini open-intralesional curettage (nmic) or navigated minimally invasive radiofrequency ablation (nmrfa) in treating these lesions.Methods: all patients who underwent surgery for oo in the foot and ankle between 2015 and 2020 were included.O-arm navigation was used in all procedures.The choice of nmic versus nmrfa was made by the surgeon according to the location of the lesion and its proximity to sensitive anatomic structures.Results: fourteen patients were included.Ten were operated by nmrfa and 4 by nmic.All patients¿ symptoms related to oo resolved following a single procedure.Average aofas score increased by 18.7 (p <(><<)>.001).Three patients had the following complications: pathologic fracture, superficial infection and transient deep peroneal nerve sensory loss.Conclusion: navigated surgical treatment of oo in the foot and ankle is accurate, efficient and safe reported events: patient no.8: pathologic fracture 4 weeks after navigated mini-open excision and burr curettage of 1st digit proximal phalanx, treated by surgical kwire fixation and allogeneic bone graft.Patient #14 experienced a transient loss of sensation in the deep peroneal nerve distribution following navigated minimally invasive rfa of oo in the distal tibia.Patient #9, underwent a nonnavigated open procedure to treat his lesion (oo in the 1st toe), not by our team.The procedure failed because the tumor was missed.Three months later, he underwent a successful navigated open curettage by our team with no recurrence after 31.3 months of follow up.

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patient in the study.Patient weight not available from the site.Event date is the online accepted date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.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.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

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

Additional information was received.It was reported that adverse events were mainly from the ablation device.

• 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: 16131475
• MDR Text Key: 307011310
• Report Number: 1723170-2023-00035
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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,Followup
• Report Date: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/12/2023
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male