Rappel de Samarys Peek Anterior Cervical Cage

Recall

RC-2015-RN-01246-1

Class I

2015-12-21

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01246-1

This hazard alert is being issued because of a random non-conformity relevant to the gold wires used as a position marker for the cervical peek cage samarys. the observed facts were that some devices within 4 lots manufactured between april 2014 and november 2015 presented missing, improperly secured, and/or incorrectly positioned gold wire markers, which may protrude 1-2 mm inside or outside the cage.Gold wires protruding from cage may cause local inflammation and/or neural or vascular injuries at treated site or distant ones by migration (in complete protrusion), which potentially can have serious consequences. the probability of these potential adverse events is however very low. to date, no customer complaint has been recorded and no adverse event or incident has been reported.

The sponsor is advising the surgeons that in the case of improper fixation of the gold wire, migration of these small dimensioned gold wires in the surrounding tissues would be easily detected on the X-ray films that are routinely taken during patient follow-up. Additionally, as exposed subjects may be often asymptomatic for a long period, surgeons must check on the routine X-ray films that position markers did not migrate. They may also warn implanted patients to report any late dysphagia, sensation of foreign bodies into their throat or suspect cough or different concerning symptoms, as this might allow early detecting a potential complication and solving it. For further information, please see http://www.tga.gov.au/alert/samarys-polyethylethylketone-anterior-cervical-cage This action has been closed-out on 30/08/2016.