Dynamic Locking Screw Stardrive 의 안전성 경고

Safety alert

2013-06-14

2013-06-14

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20130614b.html

Medical device safety alert: synthes dynamic locking screw stardrive medical device manufacturer, synthes, has issued a medical device safety alert concerning certain lots of the dynamic locking screw stardrive ø 3.7mm, self-tapping, cobalt-chrome alloy (cocrmo), sterile [length 22mm to 70mm] and ø 5.0 mm, self-tapping, cobalt-chrome alloy (cocrmo),sterile [length 32mm to 90mm]. the manufacturer received several complaints and investigations showed breakage at the bottom of the pin of the dynamic locking screw (dls). the breakages are recognized during planned implant removal of the whole construct after successful healing. there is the potential that the breakage of a dls may result in a mal-union or non-union requiring additional medical intervention. in a worst case scenario there is the potential for permanent impairment to occur in the presence of a mal-union or non-union. serious injury described as soft tissue damage/irritation and prolonged surgical procedures have been reported as a result of dls breakage. however, no known events of permanent impairment have been reported due to the breakage of a dls. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 june 2013.