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 Problem Unspecified Tissue Injury (4559)

Event Date 05/18/2022

Event Type  Injury  

Event Description

Tang, z., hu, z., zhu, z., qiao, j., mao, s., ling, c., qiu, y., liu, z.The utilization of dual second sacral alar-iliac screws for spinopelvic fixation in patients with severe kyphoscoliosis.Orthopaedic surgery.2022.14 (1457¿1468) doi: 10.1111/os.13348 objectives: as a new pelvic fixation technique, the dual s2ai screws fixation technique could provide highly stable distal strength, and have wide clinical prospect in the correction of severe kyphoscoliosis.However, the ideal trajectory parameters, indications and clinical outcomes of this technique have not been reported so far.This study aimed to determine the anatomical parameters of dual s2ai screws in the normal chinese adult population, investigating the indications of this technique and evaluating the feasibility and clinical outcomes.Methods: fifteen males and 15 females with normal pelvis underwent a pelvic ct scan to determine ideal dual s2ai screws trajectories.Sagittal angle (sa), transverse angle (ta), maximal length (ml), sacral length, and skin distance were measured.Subsequently, we retrospectively reviewed the data of 16 patients (seven males and nine females) who underwent dual s2ai screw fixation and 23 patients who underwent single s2ai screw fixation between january 2014 and december 2019.Preoperative, postoperative, and latest follow-up measurements of cobb angle, coronal balance (cb), spinal pelvic obliquity (spo), and regional kyphosis (rk) were obtained.The mean follow-up time was 16.7 7.1 months (range: 12¿30 months).Independent t-test was used to determine the difference in the analysis of the trajectories.The paired sample non-parametric wilcoxon test was performed to assess the changes in radiographic parameters between different time points and different groups.Results: for both male and females, the proximal s2ai screws had significantly higher ta and ml, but a lower sa than distal screws.Females showed significantly more caudal (sa: 25.03 2.32 vs.29.82 2.47, t = 7.742, p <(><<)> 0.001) trajectories of distal screw.Additionally, ml in the females were significantly shorter than that in males (106.81 mm 6.79 mm vs.101.63 mm 6.55 mm, t = 3.007, p = 0.003, 124.41 mm 7.57 mm vs.116.23 mm 7.03 mm, t = 4.337, p <(><<)> 0.001).Eight had unilateral and eight had bilateral dual s2ai screw placement.Respectively, both the single s2ai and dual s2ai groups showed significant postoperative improvement of cobb angle, rk angle and spo angle.In patients with dual s2ai screws fixation, two patients found that screws loosening occurred in one of dual screws at 1-year follow-up, and in patients with single s2ai screws fixation, six patients found screw loosing as well as two patients found screw breakage at 1-year follow-up.None of all patients had any prominent loss of correction.Conclusion: the ideal trajectory of dual s2ai screw could be well established.The dual s2ai screw fixation technique is feasible in patients with severe kyphoscoliosis, and provides satisfactory correction of deformity with few postoperative complications.Reportable events: single s2ai group, had two patients that underwent revision surgery.

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.

• 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: 16151551
• MDR Text Key: 307260483
• Report Number: 1723170-2023-00047
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/12/2023

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_NAV_SYS
• Device Catalogue Number: UNK_NAV_SYS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/10/2023
• Initial Date FDA 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: 36 YR
• Patient Sex: Female