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 Unspecified Infection (1930); Tissue Damage (2104); Therapeutic Response, Decreased (2271)

Event Date 09/22/2018

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of all patients in the study.Patient gender is the majority value of patients in the study.Patient weight is the mean value of all patients in the study.Device lot number, or serial number, unavailable.510(k) of the product is unavailable as the serial number of the navigation system was not provided.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

Citation: jonathan bourget-murray, md, cm, garielle e.Brown, bsc, msc.Alejandro peiro-garcia, md, madalene a.Earp, phd, david l.Parsons, md, frcsc, f abio ferri-de-barros, md, msc, fsbot, frcsc.Quality, safety, and value of innovating classic operative techniques in scoliosis surgery: interoperative traction and navigated sequential drilling.Objectives: this study aims to measure and describe the clinical and financial implications of the systematic implementation of intraoperative skull-femoral traction (iosft) and navigated sequential drilling (nsd) for posterior spinal instrumentation and fusion (psif) in adolescent idiopathic scoliosis (ais) at our institution.Summary of background data: psif has been the standard surgical treatment for ais.This retrospective single-center quality improvement study describes the perioperative outcomes and impact on health resource utilization following the systematic application of two classic surgical strategies modified using current technology: iosft and nsd.Methods: we reviewed the medical records of 125 patients who underwent a single-stage psif for ais.We identified three cohorts based on surgical strategies used intraoperatively.Traditional techniques (n 5 28), iosft (n 5 45), and iosft plus nsd (n 5 52).The primary outcome measures were operative time, prevalence of cases requiring extended operating room time, need for blood transfusion, length of hospital stay, and cost per surgery.Secondary outcomes included implant density, degree of spine deformity correction, and perioperative complications.Results: all primary outcome measures improved significantly (p !.001).Median operating time decreased by 59%.Use of late operating room hours fell from 89% to 0% and transfusion rates from 64% to 1.9%.Length of hospital stay decreased from 6 to 4 days.Comprehensive cost per case decreased by 24%.Discussion: together, iosft and nsd improved the quality, safety, and value of care.These surgical strategies were performed without increased perioperative complications, while reducing cost per case by 24%.Conclusions: the data presented may have significant implications in health resource utilization for ais surgery.Reported events: one patient in cohort a experienced a temporary drop in motor evoked potentials (meps) during the main correction.The meps were noted to fully recover with the release of the correction.The patient was noted to have normal neurologic examinations post-operative.One patient in cohort b experienced a temporary drop in motor evoked potentials (meps) during the main correction.The meps were noted to fully recover with the release of the correction.The patient was noted to have normal neurologic examinations post-operative.Three patients required revision surgery due to adding on phenomena leading to coronal decompensation following selective lumbar fusions.Three patients required revision surgery due to symptomatic prominent implants.One patient required revision surgery due to a broken pedicle screw.One patient required revision surgery due to a late infection.

• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 9035849
• MDR Text Key: 158611559
• Report Number: 1723170-2019-04871
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2019
• 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
• Date Manufacturer Received: 08/16/2019
• 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: 15 YR
• Patient Weight: 53