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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 454
Material deformation 317
Device operates differently than expected 279
Application interface becomes non-functional or program exits abnormally 230
Device stops intermittently 215
Break 197
Unintended movement 137
Unintended arm motion 114
Communication or transmission issue 109
Computer software issue 105
Device Issue 77
Device displays error message 75
Bent 71
Disassembly 70
No display or display failure 69
Mechanical issue 54
No Known Device Problem 47
Naturally worn 44
Use of Device Issue 42
Electrical issue 30
Device clogged 30
Erratic display 29
Incorrect display 27
Improper or incorrect procedure or method 26
Unstable 25
Material twisted 25
Fracture 21
Loose or intermittent connection 19
Slippage of device or device component 17
Device inoperable 17
Device Cleaning Issue 16
Calibration issue 16
Device handling issue 15
Device or device component damaged by another device 13
Connection issue 13
Occlusion within device 12
Image reversal 12
Blockage within device or device component 11
Detachment of device component 10
Mechanical jam 7
Difficult to position 7
Difficult to deploy 7
Improper device output 7
Data Issue 6
Mislocation 6
Incorrect or inadequate result 6
Positioning Issue 6
Image orientation incorrect 6
Computer operating system issue 6
Device, removal of (non-implant) 6
Material fragmentation 5
Other (for use when an appropriate device code cannot be identified) 5
No device output 5
Tip breakage 5
Interference 5
Device, or device fragments remain in patient 5
Invalid sensing 5
Dislodged or dislocated 5
Failure to calibrate 5
Difficult to open or close 4
Device abrasion from instrument or another object 4
Difficult to flush 4
Human-Device Interface Issue 4
Stretched 4
No Information 4
Burn of device or device component 4
Disconnection 4
Application program issue 4
Fitting problem 4
Poor quality image 4
Peeled 3
Optical issue 3
Device misassembled during manufacturing or shipping 3
Foreign material present in device 3
Device emits odor 3
Misassembled by Users 3
Scratched material 3
Material Distortion 3
Detachment of device or device component 3
Operating system becomes non-functional 3
Spark 3
Patient-device incompatibility 3
Suction issue 3
Incorrect measurement 3
Intermittent continuity 3
Self-activation or keying 2
Degraded 2
No code available 2
Component missing 2
Obstruction within device 2
Device Difficult to Setup or Prepare 2
Difficult to remove 2
Miscalibration 2
Device sensing issue 2
Electronic property issue 2
Failure to align 2
Device disinfection or sterilization issue 2
Device markings issue 2
Loss of power 2
Component or accessory incompatibility 2
Total Device Problems 3324

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

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