Events

Safety Alert Or Field Safety Notices for Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by manufacturer #17429.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event ID
    MDA/2007/084
  • Event Number
    CON2032938
  • Date
    2007-11-05
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032938
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Recall due to a manufacturing defect. medtronic is recalling implicated lots of colorado ii locking nuts. according to the manufacturer’s report, two thread grooves are missing on the locking nuts. final tightening may cause the locking nuts to tilt and loosen, causing damage to the thread of the bone screw such that the nuts and the bone screws have to be replaced during the same surgical procedure. the manufacturer has identified that the problem was caused by a manufacturing error and estimates that about 644 potentially affected devices have been distributed in the uk. the manufacturer wrote to users about this recall in september 2007 (see mhra website). the mhra is not aware of any adverse incidents in the uk associated with this problem. medtronic is recalling this implant as a precautionary measure. this alert is being published to facilitate the manufacturer’s recall.
  • Action
    Do not use affected devices. Quarantine affected devices. Return affected devices to the manufacturer. Report all adverse incidents associated with this device to the manufacturer and the MHRA.

Device

Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system
  • Model / Serial
  • Product Description
    Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system. Catalogue number 8634111. Lots: W07G2386, W07G2387, W07G2388, W07G2389, W07G2751, W07H0440, W07H1809 and W07H1810.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429