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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 029 08 11 000
Date submitted: 8/14/2011
Manufacturer:BrainLAB
Device Type:Brainlab Skull
Description:Brainlab Disposable Self-Tapping Screw
Medical Device Identifier:Brainlab Skull Reference Base (Art. No. 52121B) Brainlab Skull Reference Base (Art. No. 52129 & 52129A) Brainlab Disposable Self-Tapping Screw 1.5 X 6MM (Art. No. 52128) KLS Martin Cross-Drive Screw 1.5x6mm (Art. No. 25-678-06)
Reason of Field Safety Corrective Action:Applying too much torque or tensile force to the head of the screw during the use of Brainlab Skull Reference Base in combination with KLS Martin Cross-Drive screws may cause the screw head to deform or to shear off. In such case, the screw can no longer be removed using the specified screwdriver or parts of the screw may remain inside the patient’s skull bone.
Remedy Action:1. Existing potentially affected customers with above-mentioned Skull Reference Base versions receive this product notification letter. 2. Depending on the used Skull Reference Base version these customers receive the attached update to the Instructions for Use BL-IL-52121B_52129-Rev1.0 or BL-IL-60903-79-Rev2.0 regarding safe use of the Skull Reference Array kit.
Athorized Representative/Importer/Distributor:Al-Faisaliah Medical System. Riyadh (01) 2119999
Report Source:NCMDR
Source Ref. Number:BF53B5AE92307
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company
Attachments: Brainlab.pdf