Events

Alerte Ou Avis De Sécurité sur Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par manufacturer #17429.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2007/084
  • Numéro de l'événement
    CON2032938
  • Date
    2007-11-05
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032938
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    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