Events

Recall of Arsenal Set-Screw, a sub-component of the Arsenal Spinal Fixation System

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Scientx Australia.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2016-RN-01639-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-12-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01639-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    For certain lots of set screw, the manufacturer has become aware of a trend specific to set screw postoperative disengagement from the screw body (set screw back-out). 16 complaints were received from october 2015 through august 2016. in the short term, there is a risk that set screw post-operative disengagement from the screw body at the end of a construct may lead to hardware failure and/or pedicle screw pull-out on adjacent levels, and may also lead to revision surgery. the long term risk is that set screw post-operative disengagement from the screw body may lead to loss of correction, as well as the non-union/non-fusion of bone (pseudoarthrosis). there is also an unrelated issue for other lots of set screws where a small proportion of lots were manufactured in an oversized condition. for this issue, testing conducted by alphatec indicates that if the set screw is successfully inserted and locked to the required tightening torque, the construct will perform appropriately.
  • Action
    For the screw back-out issue, implanting surgeons are being informed to consider more frequent follow-up visits during the initial postoperative phase(s) after surgery. For the oversized condition issue, surgeons are advised that tightening the set screws to the prescribed tightening torque (80in-lbs) should fully mitigate the possibility of an adverse screw body splay event.

Device

Arsenal Set-Screw, a sub-component of the Arsenal Spinal Fixation System
  • Model / Serial
    Arsenal Set-Screw, a sub-component of the Arsenal Spinal Fixation SystemPart Number: 47127Lot Numbers affectedFor screw back-out issue:700942For oversized condition: 7689802, 7689803, 7766301ARTG Number: 178654
  • Manufacturer
    Scientx Australia

Manufacturer

Scientx Australia
  • Source
    DHTGA