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Medical Devices Sector قطاع الأجهزة الطبية	NCMDR National Center for Medical Devices Reporting المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
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NCMDR Recall

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Reference Number:	mdprc 011 03 12 000
Date submitted:	3/5/2012

Manufacturer:	Integra LifeSciences
Device Type:	Advansys Medial Lisfranc Plates
Description:	Plates, Bone
Medical Device Identifier:	Reference Nos.: 181041S, 181042S, 181051S, 181052S, All Batches
Reason of Field Safety Corrective Action:	Raptures of the tibialis anterior tendon from 2 weeks to 10 months alter Implantation.
Remedy Action:	Integra recommends the following: (1) Dorso-medial incision has to be performed. (2) The plate is to be placed on the bone and has to be implanted beneath the tibialis anterior tendon. (3) Never implant the screw Ø3.5 through the tibialis anterior tendon. (4) During surgery, care should be taken to maintain the attachment of the tibialis anterior tendon. (5) Never detach tibialis anterior tendon but if necessary unstuck it from the bone.
Athorized Representative/Importer/Distributor:	Al Ewan Medical Company, Riyadh, (01) 4563366
Report Source:	NCMDR
Source Ref. Number:	A6739C9EC731A
SFDA Comments:	SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:	Integra LifeSciences.pdf

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