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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
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 581
Material deformation 367
Application interface becomes non-functional or program exits abnormally 303
Device operates differently than expected 300
Device stops intermittently 258
Break 257
Unintended movement 179
Communication or transmission issue 155
Unintended arm motion 140
Computer software issue 113
Device displays error message 99
No display or display failure 98
Bent 81
Device Issue 77
Disassembly 76
No Known Device Problem 64
Mechanical issue 57
Use of Device Issue 54
Naturally worn 47
Electrical issue 37
Erratic display 34
Device inoperable 31
Unstable 31
Device clogged 30
Incorrect display 29
Improper or incorrect procedure or method 27
Material twisted 25
Fracture 23
Device handling issue 23
Loose or intermittent connection 20
Slippage of device or device component 17
Calibration issue 17
Device Cleaning Issue 16
Image reversal 14
Device or device component damaged by another device 14
Connection issue 13
Occlusion within device 12
Blockage within device or device component 11
Detachment of device component 10
Mechanical jam 8
Improper device output 8
Failure to calibrate 7
Difficult to deploy 7
Difficult to position 7
No device output 6
Mislocation 6
Incorrect or inadequate result 6
Material fragmentation 6
Image orientation incorrect 6
Device, removal of (non-implant) 6
Application program issue 6
Computer operating system issue 6
Data Issue 6
No Information 6
Positioning Issue 6
Dislodged or dislocated 5
Human-Device Interface Issue 5
Tip breakage 5
Other (for use when an appropriate device code cannot be identified) 5
Invalid sensing 5
Burn of device or device component 5
Device, or device fragments remain in patient 5
Interference 5
Device abrasion from instrument or another object 4
Poor quality image 4
Stretched 4
Disconnection 4
Difficult to flush 4
Spark 4
Fitting problem 4
Difficult to open or close 4
Foreign material present in device 3
Device misassembled during manufacturing or shipping 3
Detachment of device or device component 3
Operating system becomes non-functional 3
Optical issue 3
Material Distortion 3
Patient-device incompatibility 3
Component missing 3
Suction issue 3
Intermittent continuity 3
Device Difficult to Setup or Prepare 3
Device emits odor 3
Peeled 3
Incorrect measurement 3
Scratched material 3
Misassembled by Users 3
No code available 2
Loss of power 2
Difficult to remove 2
Self-activation or keying 2
Sensing intermittently 2
Degraded 2
Calibration error 2
False device output 2
Material frayed 2
Image display error 2
Dull 2
Miscalibration 2
Obstruction within device 2
Total Device Problems 3989

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 1 0 0 0 0 0 0 1
Class II 0 5 4 6 8 4 2 6 11 2
Class III 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 Aug-02-2016
28 Medtronic Navigation, Inc. II Mar-24-2016
29 Medtronic Navigation, Inc. II Sep-30-2015
30 Medtronic Navigation, Inc. II Aug-03-2015
31 Medtronic Navigation, Inc. II Jun-26-2015
32 Medtronic Navigation, Inc. II Jun-12-2015
33 Medtronic Navigation, Inc. II May-09-2014
34 Medtronic Navigation, Inc. II Aug-13-2013
35 Medtronic Navigation, Inc. II Nov-29-2012
36 Medtronic Navigation, Inc. II Mar-08-2012
37 Medtronic Navigation, Inc. II Jul-11-2011
38 Medtronic Neuromodulation II Jul-25-2014
39 Northern Digital Inc. II Jul-16-2015
40 Northern Digital Inc. II Jul-16-2015
41 Stryker Instruments Div. of Stryker Corporation II Jun-16-2015
42 Stryker Instruments Div. of Stryker Corporation II Jun-04-2014
43 Stryker Instruments Div. of Stryker Corporation I Nov-20-2009
44 Stryker Instruments Div. of Stryker Corporation II Sep-16-2008
45 Stryker Instruments Division of Stryker Corporation II Feb-25-2011
46 Synaptive Medical, Inc. II Dec-23-2015
47 Zimmer Inc. II Dec-22-2009
48 Zimmer Inc. II Mar-02-2009
49 Zimmer Inc. II Sep-23-2008
50 Zimmer Inc. II Sep-20-2008

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