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 Problem Death (1802)

Event Date 09/20/2018

Event Type  Death  

Manufacturer Narrative

Patient age is the mean value of the age of the patient(s) in the study.Patient gender is the majority value of the patient(s) in the study.Patient weight not available from the site.Death date is estimated as event date as the date was not provided in the literature article.Event date is the accepted date of the literature file for 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.- attachment: [barzilai_2019.Pdf].

Event Description

Citation ori barzilai, md lily mclaughlin, bs eric lis, md anne s.Reiner, mph mark h.Bilsky,md ilya laufer,md utility of cement augmentation via percutaneous fenestrated pedicle screws for stabilization of cancer-related spinal instability.Operative neurosurgery; volume 16, number 5, may 2019 background: cancer patients experience pathological fractures and the typical poor bone quality frequently complicates stabilization.Methods for overcoming screw failure include utilization of fenestrated screws that permit the injection of bone cement into the vertebral body to augment fixation.Objective: to evaluate the safety and efficacy of cement augmentation via fenestrated screws.Methods: a retrospective chart review of patients with neoplastic spinal instability who underwent percutaneous instrumented stabilization with cement augmentation using fenestrated pedicle screws.Patient demographic and treatment data and intraoperative and postoperative complications were evaluated by chart review and radiographic evaluation.Prospectively collected patient reported outcomes (pro) were evaluated at short (2-6 mo) and long term (6-12 mo).Results: cement augmentation was performed in 2016 fenestrated pedicle screws in 53 patients.Three patients required reoperation.One patient had an asymptomatic screw fracture at 6 mo postoperatively that did not require intervention.No cases of lucency around the pedicle screws, rod fractures, or cement extravasation into the spinal canalwere observed.Eight cases of asymptomatic, radiographically-detected venous extravasation were found.Systemic complications included a pulmonary cement embolism, a lower extremity deep vein thrombosis, and a postoperative mortality secondary to pulmonary failure from widespread metastatic pulmonary infiltration.Significant improvement in pro measures was found in short and long-term analysis.Conclusion: cement augmentation of pedicle screws is an effective method to enhance the durability of spinal constructs in the cancer population.Risks include cement extravasation into draining blood reported events: 1) one case of in-house mortality was documented secondary to pulmonary failure from widespread metastatic infiltration of the lungs with no evidence of pe or other cement related toxicities.

• 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: 9268712
• MDR Text Key: 164700846
• Report Number: 1723170-2019-05442
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• 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: 10/05/2019
• 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): Death
• Patient Age: 64 YR