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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 12
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 5
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 9
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material deformation 384
Break 367
Mechanical issue 261
Device operates differently than expected 174
No Information 113
No Known Device Problem 106
Material integrity issue 100
Bent 89
Imprecision 85
Disassembly 81
Computer software issue 76
Device Issue 63
Device or device component damaged by another device 61
Detachment of device or device component 57
Unintended movement 50
Use of Device Issue 47
Device displays error message 39
Fracture 37
Device clogged 33
Detachment of device component 32
Electrical issue 32
Communication or transmission issue 26
Material twisted 22
Vibration 21
Device inoperable 21
Loose or intermittent connection 20
Temperature issue 19
Connection issue 15
Malposition of device 15
Device Cleaning Issue 15
Failure to fire 14
Positioning Issue 14
Naturally worn 13
Migration of device or device component 13
Application interface becomes non-functional or program exits abnormally 12
Blockage within device or device component 11
Dislodged or dislocated 11
Material fragmentation 10
Overheating of device or device component 9
Unstable 9
Foreign material present in device 9
Computer operating system issue 9
Noise, Audible 8
Smoking 8
Occlusion within device 7
Material separation 7
Mechanical jam 7
Human-Device Interface Issue 6
Improper device output 6
Calibration issue 6
Expiration date error 6
Output issue 6
Misassembled 6
Improper or incorrect procedure or method 6
Component missing 5
Metal shedding debris 5
Device stops intermittently 5
Disconnection 4
Loss of or failure to bond 4
Physical resistance 3
Patient Data Issue 3
Device handling issue 3
Data Issue 2
Not Applicable 2
Power source issue 2
Date-related software issue 2
Patient-device incompatibility 2
Application program issue 2
Device markings issue 2
Mechanics altered 2
Electrical shorting 2
Component falling 2
Contamination during use 2
Size incorrect for patient 2
Obstruction within device 2
Fitting problem 2
Unintended collision 2
No device output 2
Incorrect or inadequate result 2
Loss of power 2
Failure to power-up 1
Incorrect software programming calculations 1
Difficult to remove 1
Failure to read input signal 1
Difficult to position 1
Poor quality image 1
Device emits odor 1
Device damaged prior to use 1
Defective component 1
Electro-static discharge 1
Cut in material 1
Failure to deliver 1
Slippage of device or device component 1
Sticking 1
Crack 1
Degraded 1
Failure to conduct 1
Calibration error 1
Circuit Failure 1
Component incompatible 1
Total Device Problems 2762

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 5
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 Orthosoft, Inc. dba Zimmer CAS II Apr-26-2017
17 Orthosoft, Inc. dba Zimmer CAS II Apr-19-2017
18 Smith & Nephew Inc II Nov-18-2010
19 Zimmer Biomet, Inc. II Mar-27-2017
20 Zimmer CAS II Jun-02-2015

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