Spinal implants - locking nuts used in the Medtronic Colorado II spinal implant system 를 위한 안전성 경고 / 현장 안전성 서한

Safety alert / Field Safety Notice

MDA/2007/084

CON2032938

2007-11-05

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON2032938

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.

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.