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 Nerve Damage (1979); Paralysis (1997); Unspecified Tissue Injury (4559)

Event Date 11/12/2023

Event Type  Injury  

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 accepted 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.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

Gurel, r., shehadeh, k., elbaz, e., benady, a., factor, s., ashkenazi, i., gortzak, y., sternheim, a., dadia, s., segal, o.Intraoperative three-dimensional navigation for surgical treatment of osteoid osteoma in the upper extremity: a series of 19 cases.Journal of orthopaedic surgery 2023.31(3) 1¿10.Doi: 10.1177/10225536231217123.Abstract the surgical treatment for osteoid osteoma (oo) in the upper extremity is challenging due to the difficulty in locating the lesion and the crowding of sensitive structures within the anatomy.This study aimed to describe the outcomes of navigated minimally invasive radiofrequency ablation and those of navigated mini open-intralesional curettage in treating these lesions.Nineteen consecutive patients with oo in the upper limb who underwent navigated surgery were included.The average quickdash and numeric pain rating scale improved from 62.2 ± 23.7 to 11.7 ± 16.9 and from 8.1 ± 1.6 to 0.5 ± 1.8, respectively (p.01 each) following the procedure.Two complications were recorded: one patient had persistent radial nerve palsy, and one patient had transient partial radial nerve weakness.In conclusion, navigation is an important tool in the surgical treatment of oo in the upper limb.A mini open approach to identify and protect neurovascular structures is recommended.Reported events one patient had neither pain nor functional improvement following her surgery (patient #4).She underwent a second arthroscopic surgery 6 months following her first operation which also did not improve her symptoms.Patient #2 re-nmrfa 24 months after the primary nmrfa due to recurrence.Resolution of symptoms following re-nmrfa patient #15 re nmrfa 12 months following primary nmrfa due to persistance of symptoms.Resolution of symptoms following re-nmrfa patient #17 re nmrfa 10 months following primary nmrfa due to persistance of symptoms.Resolution of symptoms following re-nmrfa another patient (patient #7) had complete resolution of her oo-related symptoms, but she sustained complete persistent radial palsy following navigated minimally invasive radio frequency ablation (nmrfa).Patient #10 had complete resolution of his oo-related symptoms, although he sustained transient partial radial nerve weakness which completely resolved.See attached literature article.

• 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: 18366659
• MDR Text Key: 331048387
• Report Number: 1723170-2023-02846
• 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
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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: 12/08/2023
• 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: 28 YR
• Patient Sex: Male