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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthopedic stereotaxic instrument
Regulation Description Stereotaxic instrument.
Definition Stereotaxic guidance during orthopedic surgery procedures. Indicated for Orthopedic joint or spine surgery. Neurological stereotaxic instruments are classified under product code HAW.
Product CodeOLO
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
ALPHATEC
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 8
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 8
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material deformation 354
Break 343
Mechanical issue 208
Device operates differently than expected 135
No Known Device Problem 88
Bent 85
No Information 75
Material integrity issue 70
Computer software issue 68
Imprecision 65
Device Issue 63
Device or device component damaged by another device 61
Unintended movement 49
Disassembly 44
Use of Device Issue 41
Detachment of device or device component 41
Device clogged 32
Detachment of device component 32
Device displays error message 30
Fracture 29
Electrical issue 24
Material twisted 22
Vibration 20
Device inoperable 20
Temperature issue 19
Communication or transmission issue 15
Malposition of device 15
Device Cleaning Issue 15
Failure to fire 14
Positioning Issue 14
Naturally worn 13
Blockage within device or device component 11
Application interface becomes non-functional or program exits abnormally 11
Migration of device or device component 10
Material fragmentation 10
Connection issue 10
Dislodged or dislocated 10
Loose or intermittent connection 9
Unstable 9
Overheating of device or device component 9
Smoking 8
Foreign material present in device 8
Noise, Audible 8
Computer operating system issue 7
Occlusion within device 7
Misassembled 6
Expiration date error 6
Improper or incorrect procedure or method 6
Human-Device Interface Issue 6
Improper device output 6
Output issue 6
Mechanical jam 5
Metal shedding debris 5
Component missing 5
Device stops intermittently 5
Material separation 5
Disconnection 4
Loss of or failure to bond 3
Physical resistance 3
Device handling issue 3
Patient Data Issue 2
Calibration issue 2
Application program issue 2
Mechanics altered 2
Electrical shorting 2
Power source issue 2
Component falling 2
Contamination during use 2
No device output 2
Loss of power 2
Incorrect or inadequate result 2
Size incorrect for patient 2
Fitting problem 2
Obstruction within device 2
Cut in material 1
Failure to separate 1
Patient-device incompatibility 1
Device damaged prior to use 1
Failure to deliver 1
Electro-static discharge 1
Slippage of device or device component 1
Sticking 1
Failure to power-up 1
Incorrect software programming calculations 1
Difficult to remove 1
Failure to read input signal 1
Difficult to position 1
Device emits odor 1
Poor quality image 1
Device abrasion from instrument or another object 1
Incorrect measurement 1
Material frayed 1
Difficult to insert 1
Instruction for use issue 1
Inadequate instructions for healthcare professional 1
Crack 1
Failure to conduct 1
Fluid leak 1
Premature discharge of battery 1
Calibration error 1
Total Device Problems 2359

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 1 1 1 0 2 5 4 2
Class III 0 0 0 0 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Blue Belt Technologies MN II May-09-2014
2 Brainlab AG II Feb-26-2015
3 Mako Surgical Corporation II Mar-07-2017
4 Mako Surgical Corporation II Feb-11-2017
5 Mako Surgical Corporation II Apr-29-2016
6 Mako Surgical Corporation II Apr-28-2016
7 Mako Surgical Corporation II Apr-18-2016
8 Mako Surgical Corporation II Nov-05-2015
9 Mako Surgical Corporation II Feb-19-2015
10 Mako Surgical Corporation II Dec-18-2014
11 Mako Surgical Corporation II Nov-19-2012
12 Mako Surgical Corporation II Nov-01-2011
13 Medtronic Navigation, Inc. II Aug-02-2016
14 Medtronic Navigation, Inc. II Sep-30-2015
15 OMNI LIFE SCIENCE III Nov-17-2016
16 Smith & Nephew Inc II Nov-18-2010
17 Zimmer CAS II Jun-02-2015

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