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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
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 5
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material deformation 347
Break 337
Mechanical issue 197
Device operates differently than expected 131
No Known Device Problem 86
Bent 81
Computer software issue 68
Material integrity issue 66
Device Issue 63
Device or device component damaged by another device 61
Imprecision 60
Unintended movement 50
No Information 46
Detachment of device or device component 40
Use of Device Issue 39
Device clogged 32
Detachment of device component 32
Device displays error message 29
Disassembly 27
Fracture 27
Electrical issue 23
Material twisted 23
Vibration 20
Device inoperable 19
Temperature issue 19
Communication or transmission issue 15
Malposition of device 15
Device Cleaning Issue 14
Failure to fire 14
Positioning Issue 14
Naturally worn 12
Application interface becomes non-functional or program exits abnormally 11
Blockage within device or device component 11
Migration of device or device component 11
Material fragmentation 10
Dislodged or dislocated 10
Connection issue 10
Loose or intermittent connection 9
Unstable 9
Smoking 8
Overheating of device or device component 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
Component missing 5
Metal shedding debris 5
Material separation 5
Device stops intermittently 4
Disconnection 4
Loss of or failure to bond 3
Physical resistance 3
Obstruction within device 2
Fitting problem 2
No device output 2
Incorrect or inadequate result 2
Loss of power 2
Size incorrect for patient 2
Component falling 2
Contamination during use 2
Mechanics altered 2
Electrical shorting 2
Power source issue 2
Not Applicable 2
Calibration issue 2
Patient Data Issue 2
Device handling issue 2
No code available 1
Data Issue 1
Device markings issue 1
Incorrect device or component shipped 1
Device packaging compromised 1
Device sensing issue 1
Device-device incompatibility 1
Packaging issue 1
Environmental Particulates 1
Material Protrusion 1
Osseointegration issue 1
Crack 1
Fluid leak 1
Failure to conduct 1
Calibration error 1
Circuit Failure 1
Poor quality image 1
Device abrasion from instrument or another object 1
Device emits odor 1
Difficult to position 1
Incorrect measurement 1
Material frayed 1
Difficult to insert 1
Instruction for use issue 1
Inadequate instructions for healthcare professional 1
Slippage of device or device component 1
Total Device Problems 2260

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 1
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 Feb-11-2017
4 Mako Surgical Corporation II Apr-29-2016
5 Mako Surgical Corporation II Apr-28-2016
6 Mako Surgical Corporation II Apr-18-2016
7 Mako Surgical Corporation II Nov-05-2015
8 Mako Surgical Corporation II Feb-19-2015
9 Mako Surgical Corporation II Dec-18-2014
10 Mako Surgical Corporation II Nov-19-2012
11 Mako Surgical Corporation II Nov-01-2011
12 Medtronic Navigation, Inc. II Aug-02-2016
13 Medtronic Navigation, Inc. II Sep-30-2015
14 OMNI LIFE SCIENCE III Nov-17-2016
15 Smith & Nephew Inc II Nov-18-2010
16 Zimmer CAS II Jun-02-2015

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