Pathfinder System Polyaxial Pedicle Screws

• • Terminated Z-0075-2011 FDA Unclassified (pre-2012) ·initiated 13 Apr 2010

  The tip of the PathFinder End Screw Extender Sleeve has fractured during use. In some cases, this instrument fracture led to surgical delay or additional surgical steps necessary to remove the fragments of the broken tip.

• • Terminated Z-2335-2010 FDA Unclassified (pre-2012) ·initiated 12 Jan 2009 ·on shared 510(k) K071174

  The screwdriver may fracture, resulting in surgical delays and/or fragments going into the surgical site.

• • Terminated Z-1784-2008 FDA Unclassified (pre-2012) ·initiated 17 Apr 2008

  Breakage - Tips on the Pathfinder Bone Awl may bend or break prematurely. The firm has received internal non-conformances and complaints where the tips of the Awl were worn and damaged. Of the tip breaks, six have had material missing. During the same period, there were 15 complaints reported where the tip broke off at the weld after repeated use (1-3 years). The firm found several possible ca

• • Terminated Z-1593-2008 FDA Unclassified (pre-2012) ·initiated 24 Mar 2008 ·on shared 510(k) K071174

  Reports received regarding disassembly of T-Handle Driver components during surgery dropping the closure top into the surgical site.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K071174 ↗

FDA Product Code

NKB

Device Class

Class II

Regulation

21 CFR Part 888.3070

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

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