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

Model Number UNK_NAV_SYS

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

Patient Problems Pain (1994); Tissue Damage (2104); Impaired Healing (2378)

Event Date 01/24/2015

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of patients in the study. Patient gender is the majority value of patients in the study. Patient weight not available from the site. Event date is the accepted date of the publication. Device lot number, or serial number, unavailable. No parts have been received by the manufacturer for evaluation. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. Other relevant device(s) are: product id: unk_oarm_sys, serial/lot #: unk. If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: r. Andrew glennie, nicolas dea, brian k. Kwon, john t. Street. Early clinical results with cortically based pedicle screw trajectory for fusion of the degenerative lumbar spine. Journal of clinical neuroscience 22 (2015)972-975. Doi. Org/10. 1016/j. Jocn. 2015. 01. 010 abstract: this study reviews the outcomes and revision rates of degenerative lumbar fusion surgery using cortical trajectory pedicle screws in lieu of traditional pedicle screw instrumentation. Pedicle screw fixation can be a challenge in patients with low bone mineral density. Wide posterior approaches to the lumbar spine exposing lateral to the facet joints and onto transverse processes causes an additional degree of muscular damage and blood loss not present with a simple laminectomy. A cortical bone trajectory pedicle screw has been proposed as an alternative to prevent screw pullout and decrease the morbidity associated with the wide posterior approach to the spine. We present a series of eight consecutive patients using a cortical bone trajectory instead of traditional pedicle screw fixation for degenerative conditions of the lumbar spine. A retrospective review of our institutional registry data identified eight patients who had cortical screws placed with the assistance of o-arm stealth navigation (medtronic sofamor danek, memphis, tn, usa) from 2010¿2013. We analyzed the need for revision, the maintenance of reduction and the incidence of screw pullout or breakage. Our review demonstrated that two of eight patients were revised at an average of 12 months. The reasons for these revisions were pseud arthrosis and caudal adjacent segment failure. All patients who were revised had frank screw loosening. We present early clinical results of a new technique that has been shown to have a better fixation profile in laboratory testing. Our less than favorable early clinical results should be interpreted with caution and highlight important technical issues which should be considered. Reported events: 64 yr male had screws revised 12 months after the operation as back pain was noted. 82 yr female had screws revised 12 months after the operation as back pain and pseudarthrosis were noted.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: INSTRUMENT, STEREOTAXIC
• 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10831372
• MDR Text Key: 217667676
• Report Number: 1723170-2020-02976
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• 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

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/06/2020
• 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 Treatment Data

Date Received: 11/12/2020 Patient Sequence Number: 1