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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 086 05 17 000
Date submitted: 5/17/2017
Manufacturer:Medtronic
Device Type:NavLock Trackers Used with StealthStation Systems
Description:Stereotactic Systems, Image-Guided, Surgical, Intracranial
Medical Device Identifier:Products: Part Nos.:
Driver, Gray Assembly 9734228
Driver, Orange Assembly 9734259
Driver, Violet Assembly 9734315
Instrument Set NavLock 9734489
Instrument Set, Universal NavLock 9734833
NavLock Kit, Violet 9734837
NavLock Tracker Universal Green 9734734
NavLock Tracker Universal Grey 9734590
NavLock Tracker Universal Orange 9734683
NavLock Tracker Universal Violet 9734682
Tracker Kits, NavLock Universal Green 9734914
Tracker Kits, NavLock Universal Grey 9734906
Tracker Kits, NavLock Universal Orange 9734907
Tracker Kits, NavLock Universal Violet 9734908
NavLock TrackerTM and associated sets and kits: 9735120
Reason of Field Safety Corrective Action:Manufacturer Reinforces Warning That Device Should Be Used Only with Medtronic Instruments
Remedy Action:Medtronic states that you should use only Medtronic instruments with the NavLock tracker. Medtronic is revising the indications for use and strengthening the warning statement in the NavLock instructions as follows:
•Revised Indications for Use: The NavLock Trackers are intended to enable navigation of Medtronic instrumentation used during spinal fusion and interbody procedures with the Medtronic StealthStation surgical navigation system. The NavLock Trackers should only be used with Medtronic instruments.
•Strengthened Warning: The NavLock Tracker is designed and tested for use only with Medtronic instruments. The use of non-Medtronic instruments with the NavLock Tracker may result in inaccuracy, leading to serious injury or death.
Athorized Representative/Importer/Distributor:Medtronic Saudi Arabia
Report Source:NCMDR
Source Ref. Number:EC3CFAA8BB385
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Medtronic.pdf