MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) MEDTRONIC NAVIGATION; IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE

Model Number UNK_OARM_SYS

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Thrombosis (2100); Tissue Damage (2104); Impaired Healing (2378); Post Operative Wound Infection (2446)

Event Date 07/26/2020

Event Type  Injury  

Manufacturer Narrative

Patient age is average age of patients in group a for the article.Patient gender is the majority gender of patients in group a for the article.Patient weight was not included in the journal article.Please note that this date is based off of the date the article was accepted for publication as the event dates were not provided in the published literature.Article citation is included.System product number and serial number not provided in journal article.Udi not available for this system.No 510k provided as system is unknown.No evaluation was performed as this event was reported in literature.Device manufacturing date is unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Citation: wang, zhi-wei, et al.¿precise surgical treatment of thoracic ossification of ligamentum flavum assisted by o-arm computer navigation: a retrospective study.¿ world neurosurgery, no.2020, 26 jul.2020, pp.E1¿e10, doi:https://doi.Org/10.1016/j.Wneu.2020.07.196.Abstract: objective: o-arm computer navigation-assisted technology (oacnat) has been widely used in the treatment of thoracic ossification of ligamentum flavum (tolf) in recent years, but there are few in-depth studies on the safety and effectiveness of this approach.The purpose of this study was to investigate the clinical effect of accurate surgical treatment for tolf with oacnat.Methods: from january 2010 to january 2018, the clinical data of 64 patients with tolf who underwent laminectomy and internal fixation in the third hospital of hebei medical university were retrospectively reviewed.The patients were divided into group a (with oacnat, n = 33) and group b (without oacnat, n = 31) according to the application of oacnat during the operation.The possible operation-related variables, imaging results, and clinical effects were compared between the 2 groups.Results: in terms of demographics, there were no significant differences between group a and group b in age, sex, body mass index, smoking, drinking, heart disease, hypertension and diabetes (p > 0.05).In terms of operation-related variables, imaging results, and clinical efficacy, there were significant differences in operation time, wound length, postoperative modified japanese orthopaedic association (joa) score, joa score improvement rate, accuracy of screw placement, number of intraoperative fluoroscopy procedures, and cerebrospinal fluid leakage between group a and group b (p <(><<)> 0.05).There were no significant differences in other variables between the 2 groups (p > 0.05).In contrast to group a, in group b, 2 patients had incorrect segmental localization, 3 patients had residual ossified ligamentum flavum after the operation, and 1 patient had postoperative neurologic impairment.On further analysis, compared with group b, group a had a shorter operation time, more accurate screw placement, fewer fluoroscopy procedures, high er joa score improvement rate, and lower incidence of complications.Conclusions: the use of oacnat accurately located the position, size, shape, and boundary of ossification of the ligamentum flavum during the operation, which could guide accurate decompression and improve the accuracy of pedicle screw placement.This approach not only reduced the incidence of incorrect segmental localization and incomplete or excessive decompression but also reduced the risk of related complications and improved the accuracy, safety, and effectiveness of the operation.Reported event: 1.In group a, there were 5 instances of wound infection, 4 instances of delayed wound healing, 1 instance of cerebrospinal fluid leakage (caused by dural tears), 2 instances of thrombosis of the lower extremities, and 4 instances of other complications.It was also noted that after screw placement, a 3d scan was performed to observe the screw position, and the screw position was adjusted immediately if necessary.See attached article.

• Brand Name: MEDTRONIC NAVIGATION
• Type of Device: IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE
• 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: tricha miles ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635140379
• MDR Report Key: 10543699
• MDR Text Key: 207743712
• Report Number: 3004785967-2020-01083
• Device Sequence Number: 1
• Product Code: OXO
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Initial Date Manufacturer Received: 09/11/2020
• Initial Date FDA Received: 09/16/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR