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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device neurological stereotaxic instrument
Regulation Description Stereotaxic instrument.
Product CodeHAW
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 15
AD-TECH
  SUBSTANTIALLY EQUIVALENT 2
AESCULAP
  SUBSTANTIALLY EQUIVALENT 4
ARC SURGICAL LLC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 3
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 47
CARL ZEISS MEDITEC INC
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 4
EBI, L.P.
  SUBSTANTIALLY EQUIVALENT 2
Elekta Instrument AB
  SUBSTANTIALLY EQUIVALENT 14
FHC, INC.
  SUBSTANTIALLY EQUIVALENT 6
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
INTEGRATED MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
KINAMED, INC.
  SUBSTANTIALLY EQUIVALENT 4
LEIBINGER
  SUBSTANTIALLY EQUIVALENT 1
MAKO SURGICAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MAYO CLINIC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 14
MONTERIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NOMOS
  SUBSTANTIALLY EQUIVALENT 3
NUVASIVE
  SUBSTANTIALLY EQUIVALENT 1
Ohio Medical Corporation
  SUBSTANTIALLY EQUIVALENT 4
ORTHOVITA
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 10
PLUS ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 3
SCHAERER MAYFIELD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 8
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 15
SURGICAL NAVIGATION TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 15
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 5

Device Problems
Imprecision 921
Material deformation 537
Device operates differently than expected 468
Application interface becomes non-functional or program exits abnormally 466
Device stops intermittently 405
Communication or transmission issue 328
Break 318
Unintended movement 246
Unintended arm motion 180
Device displays error message 165
Disassembly 160
Computer software issue 158
No display or display failure 145
Bent 114
Device Issue 111
No Known Device Problem 93
Mechanical issue 77
Use of Device Issue 70
Electrical issue 62
Naturally worn 62
Device inoperable 57
Erratic display 44
Device clogged 44
Incorrect display 40
Unstable 34
Improper or incorrect procedure or method 33
Fracture 33
Device handling issue 31
Material twisted 30
Device or device component damaged by another device 26
Loose or intermittent connection 24
Device Cleaning Issue 23
Image reversal 20
Calibration issue 19
Slippage of device or device component 18
Detachment of device component 17
Connection issue 16
Occlusion within device 15
No device output 14
Blockage within device or device component 13
Improper device output 11
Mechanical jam 11
Positioning Issue 10
Material fragmentation 9
Poor quality image 9
Difficult to position 9
Device emits odor 8
Difficult to deploy 7
Dislodged or dislocated 7
Application program issue 7
Failure to calibrate 7
Device, removal of (non-implant) 6
Computer operating system issue 6
Burn of device or device component 6
Mislocation 6
Image orientation incorrect 6
Incorrect or inadequate result 6
No Information 6
Data Issue 6
Device, or device fragments remain in patient 5
Interference 5
Human-Device Interface Issue 5
Spark 5
Tip breakage 5
Other (for use when an appropriate device code cannot be identified) 5
Invalid sensing 5
Stretched 4
Patient-device incompatibility 4
Fitting problem 4
Difficult to open or close 4
Difficult to flush 4
Device abrasion from instrument or another object 4
Disconnection 4
Material frayed 3
Failure to Adhere or Bond 3
Intermittent continuity 3
Degraded 3
Incorrect measurement 3
Peeled 3
Device Difficult to Setup or Prepare 3
Foreign material present in device 3
Material Distortion 3
Device misassembled during manufacturing or shipping 3
Device sensing issue 3
Detachment of device or device component 3
Obstruction within device 3
Component missing 3
Suction issue 3
Misassembled by Users 3
Scratched material 3
Operating system becomes non-functional 3
Optical issue 3
Output issue 3
Power source issue 2
Temperature issue 2
No code available 2
Out-of-box failure 2
Dull 2
Miscalibration 2
Failure to align 2
Total Device Problems 5917

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 1 0 0 0 0 0 0 1 0
Class II 0 5 4 6 8 4 2 6 11 2 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Brainlab AG I Jan-19-2016
2 Brainlab AG II Nov-17-2015
3 Brainlab AG II Nov-11-2015
4 Brainlab AG II Aug-13-2014
5 Brainlab AG II Apr-17-2014
6 Brainlab AG II Feb-10-2014
7 Elekta, Inc. II Nov-04-2013
8 Elekta, Inc. II Nov-30-2011
9 Elekta, Inc. II Feb-15-2011
10 Elekta, Inc. II Apr-22-2010
11 FHC, Inc. II Nov-03-2010
12 FHC, Inc. II Dec-22-2008
13 GE OEC Medical Systems, Inc II Jul-11-2012
14 Integra LifeSciences Corp. II Oct-06-2015
15 Integra LifeSciences Corp. II Feb-23-2011
16 Integra LifeSciences Corporation II Sep-20-2012
17 Mako Surgical Corporation II Oct-19-2009
18 Mako Surgical Corporation II Feb-11-2009
19 Medtronic Image Guided Neurologics, Inc. II Feb-07-2008
20 Medtronic Navigation, Inc II Oct-03-2011
21 Medtronic Navigation, Inc II Mar-04-2011
22 Medtronic Navigation, Inc II Feb-04-2011
23 Medtronic Navigation, Inc II Dec-17-2010
24 Medtronic Navigation, Inc II Oct-26-2010
25 Medtronic Navigation, Inc II Jul-17-2010
26 Medtronic Navigation, Inc II Mar-03-2010
27 Medtronic Navigation, Inc. II Jan-11-2017
28 Medtronic Navigation, Inc. II Aug-02-2016
29 Medtronic Navigation, Inc. II Mar-24-2016
30 Medtronic Navigation, Inc. II Sep-30-2015
31 Medtronic Navigation, Inc. II Aug-03-2015
32 Medtronic Navigation, Inc. II Jun-26-2015
33 Medtronic Navigation, Inc. II Jun-12-2015
34 Medtronic Navigation, Inc. II May-09-2014
35 Medtronic Navigation, Inc. II Aug-13-2013
36 Medtronic Navigation, Inc. II Nov-29-2012
37 Medtronic Navigation, Inc. II Mar-08-2012
38 Medtronic Navigation, Inc. II Jul-11-2011
39 Medtronic Neuromodulation II Jul-25-2014
40 Northern Digital Inc. II Jul-16-2015
41 Northern Digital Inc. II Jul-16-2015
42 Stryker Instruments Div. of Stryker Corporation II Jun-16-2015
43 Stryker Instruments Div. of Stryker Corporation II Jun-04-2014
44 Stryker Instruments Div. of Stryker Corporation I Nov-20-2009
45 Stryker Instruments Div. of Stryker Corporation II Sep-16-2008
46 Stryker Instruments Division of Stryker Corporation II Feb-25-2011
47 Synaptive Medical, Inc. II Dec-23-2015
48 Zimmer Inc. II Dec-22-2009
49 Zimmer Inc. II Mar-02-2009
50 Zimmer Inc. II Sep-23-2008
51 Zimmer Inc. II Sep-20-2008

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