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Signals from Device Events
April 2020

Signals is a quarterly medical device adverse events newsletter.


DEVICE SPOTLIGHT
                        
Spinal Stabilization & Fusion Systems
NOTE: The following Adverse Event data was extracted from the FDA MAUDE database using Device Events, a cloud-based software service that extracts, consolidates and provides comprehensive reports and trends on the millions of medical device adverse event reports that have been submitted to the FDA. 
DEVICE NAME: 
     PRODUCT CODE - DESCRIPTION                                                                                                     
     KWP                      - Appliance, Fixation, Spinal Interlaminal
     KWQ                      - Appliance, Fixation, Spinal Intervertebral Boday
     MNH                      - Orthosis, Spondylolisthesis Spinal Fixation
     MNI                        - Orthosis, Spinal Pedicle Fixation
     KNB                       - Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease
     OSH                       - Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

REPORTING PERIOD: JANUARY 2010 - MARCH 2020 
 
ADVERSE EVENTS RECEIVED BY THE FDA FROM:
  • TOTAL........................34,500
  • INJURY.......................20,099
  • MALFUNCTION..........13,983
  • DEATH.............................131
  • OTHER............................287   

Top 3 Manufacturers of Spinal Stabilization & Fusion Systems Reporting Adverse Events

Spinal Stabilization & Fusion Systems - Adverse Event Trend - Deaths


Spinal Stabilization & Fusion Systems - Adverse Event Trend - Injury



Spinal Stabilization & Fusion Systems - Adverse Event Trend - Malfunctions

IN THE NEWS
NuVasive suspends UK sales of Magec rod amid safety concerns

April 2, 2020 - MEDTECH DIVE - BRIEF 
  • NuVasive has suspended the supply of Magec rods to the U.K. and Ireland while regulators investigate the risk posed by faulty devices used in treating scoliosis. ​
  • In a statement Wednesday, the U.K. device regulator said NuVasive had voluntarily taken the action in light of reports of an actuator end cap component separating after implantation.
  • NuVasive has previously warned that the problem “could be costly” if the device needs to be redesigned or re-engineered to support its continued use, creating financial headwinds.
View Full Article
* * *
 
OrthoPediatrics buys FDA-approved scoliosis tech, challenging Zimmer for market
April 2, 2020 - MEDTECH DIVE - BRIEF
  • Warsaw, Indiana-based medtech OrthoPediatrics said Wednesday it acquired startup ApiFix, which last August received a humanitarian device exemption (HDE) from FDA for a device alternative to spinal fusion surgery for progressive adolescent idiopathic scoliosis.
  • The deal gives ApiFix 934,768 shares of OrthoPediatrics common stock, $2 million in cash paid at closing, and milestone payments over four years, according to the announcement. 
  • The addition of the minimally invasive deformity correction, or MID-C, system comes as OrthoPediatrics anticipates significant impact to its deformity correction and scoliosis businesses from postponement of elective procedures during the COVID-19 pandemic
 View Full Article
* * *
 
New medical device for scoliosis treatment approved by FDA
Spinal fusion is not the only option; anterior vertebral body tethering (VBT) is an innovative surgical procedure for some young teens coping with scoliosis
August 16, 2019 - ASRA - Shriners Hospital for Children - A new medical device for treating scoliosis – curvature of the spine – has received FDA approval, providing an alternative that both corrects the curve and maintains flexibility in the spine.

The FDA’s clearance is for The Tether™, which uses patented methods and techniques developed by medical staff of Shriners Hospitals for Children — Philadelphia. It is the first commercially available product used specifically for VBT, anterior vertebral body tethering, a surgical procedure for patients with scoliosis who meet very specific criteria. VBT is an alternative to spinal fusion procedures.


View Full Article
* * *
High-risk devices with expedited reviews more likely to be recalled, research suggests
March 31, 2020 - MEDTECH DIVE - BRIEF
  • Medical devices approved after receiving priority review from FDA are more likely to be recalled than high-risk products authorized via the standard route, according to findings published in a JAMA Internal Medicine research letter on Monday.
  • An analysis of 230 Class III products approved from 2005 to 2015 found 62% of devices that received some form of expedited review were recalled, compared to 30% of those with standard review. Despite having special status, priority review took longer than the standard process, on average.
  • With FDA stepping up its Breakthrough Devices Program, the researchers used the data to argue for the establishment of new safeguards during the approval process and stronger postmarket surveillance practices.
View Full Article
 

ABOUT DEVICE EVENTS
Device Events LLC is a Pennsylvania-based company that provides a cloud-based software service that extracts, consolidates and provides clear and comprehensive metrics and reports on the millions of complex medical device adverse event reports (MDRs) and recalls that have been filed with the FDA.
 · Our service helps all organizations associated with healthcare by providing them with clear, comprehensive and cost effective access to the most up to date information on problem medical devices. ·  We are committed to making information on problem devices easily accessible to our customers so they can improve health outcomes and patient safety while reducing risk for their organizations.  For more information visit our website at www.deviceevents.com
Copyright © 2020 Device Events, Inc, All rights reserved.


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