MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC (LITTLETON) MEDTRONIC NAVIGATION

Model Number UNK_OARM_SYS

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

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 12/01/2019

Event Type  Injury  

Manufacturer Narrative

Patient information was not included in the journal article.This value is the median age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date the article was published as the event dates were not provided in the published literature.Article citation is included.No product code provided as the system is unknown.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: wanru duan, yueqi du, tengfei qi, bowen jiang, kai wang, zhenlei liu, jian guan, xingwen wang, hao wu, zan chen, fengzeng jian, the value and limitation of cervical traction in the evaluation of the reducibility of atlantoaxial dislocation and basilar invagination using the intraoperative o-arm, world neurosurgery, volume 132, 2019, pages e324-e332, issn 1878-8750, https://doi.Org/10.1016/j.Wneu.2019.08.160.Summary: objective: to assess the value and limitation of cervical traction in the evaluation of the reducibility of atlantoaxial dislocation (aad) and basilar invagination (bi) using the intraoperative o-arm.Methods: a total of 22 patients with hyperextensive, irreducible aad were included.The cervical traction test under general anesthesia was performed, and the degree of reduction was evaluated using the o-arm before the operation started.The traction effects both vertically and horizontally were evaluated.All cases then underwent modified direct posterior reduction and fixation.Clinical outcomes were evaluated using the japanese orthopaedic association (joa) scale.Radiologic measurements included the anterior atlantodental interval, the distance of odontoid tip above chamberlain line, and the clivusecanal angle.Magnetic resonance imaging signal changes, size of syringomyelia, and the space ventral to medulla also were used to evaluate the postoperative reduction result.Results: after the cervical traction test, 7 patients achieved incomplete reduction, 5 achieved only vertical reduction, 6 achieved only horizontal reduction, and 4 achieved complete reduction in both horizontal and vertical orientations as assessed by the o-arm.All patients underwent a direct reduction technique.The mean joa score increased from 11.1 to 14.5.Complete reduction of aad and bi were achieved in 19 patients (86.4%), with partial reduction achieved in 3 (13.6%).Sufficient cerebrospinal fluid space anterior to the medulla with improved joa score was achieved in the 3 partially reduced patients.Conclusions: with the innovations of direct posterior reduction techniques, cervical traction under anesthesia may not sufficiently predict the reducibility of bi and aad.Cervical traction still plays an important role during the direct posterior reduction procedure.Reported events: one patient had superficial infection and recovered in one month after antibiotic therapy.Six patients complained of neck pain immediately after surgery with resolution of the pain at 3 months.One patient had posterior superior iliac crest pain that resolved in one month.

• Brand Name: MEDTRONIC NAVIGATION
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9569290
• MDR Text Key: 178749788
• Report Number: 3004785967-2020-00036
• Device Sequence Number: 1
• Product Code: IZL
• 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: 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2020
• 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
• Date Manufacturer Received: 01/02/2020
• 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: 42 YR