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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
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 13
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
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
Computer software issue 66
Device operates differently than expected 58
Imprecision 52
Device stops intermittently 34
Application interface becomes non-functional or program exits abnormally 33
Mechanical issue 29
Unintended arm motion 19
Material deformation 18
Fracture 16
Device clogged 13
Break 12
Naturally worn 11
Bent 11
Material twisted 10
Communication or transmission issue 9
Device Cleaning Issue 9
Occlusion within device 8
Connection issue 8
Device displays error message 7
Improper or incorrect procedure or method 7
Use of Device Issue 7
Mislocation 6
Slippage of device or device component 6
Device, removal of (non-implant) 6
Image orientation incorrect 6
Difficult to deploy 6
Erratic display 5
Invalid sensing 5
Tip breakage 5
Difficult to position 5
Other (for use when an appropriate device code cannot be identified) 5
Calibration issue 5
Interference 5
Image reversal 5
Device, or device fragments remain in patient 5
Computer operating system issue 5
Mechanical jam 5
Human-Device Interface Issue 4
Stretched 4
Incorrect display 4
Difficult to flush 4
Detachment of device component 4
Data Issue 4
No Known Device Problem 4
Electrical issue 4
Loose or intermittent connection 4
Scratched material 3
Unintended movement 3
Improper device output 3
Poor quality image 3
Operating system becomes non-functional 3
Application program issue 3
Spark 2
Difficult to remove 2
Loss of power 2
Component or accessory incompatibility 2
Incorrect measurement 2
Device Difficult to Setup or Prepare 2
Device abrasion from instrument or another object 2
Dislodged or dislocated 2
Failure to align 2
Peeled 2
Sensing intermittently 2
Miscalibration 2
Blockage within device or device component 2
Image display error 2
Electronic property issue 2
Optical issue 2
Intermittent continuity 2
Positioning Issue 2
Residue after decontamination 1
Difficult to Program or Calibrate 1
Volume accuracy issue 1
Disconnection 1
Entrapment of device or device component 1
Power source issue 1
Material integrity issue 1
Image resolution poor 1
Device inoperable 1
Unstable 1
Failure to obtain samples 1
Issue with displayed error message 1
Device Contamination with biological material 1
Device sensing issue 1
No Information 1
Inadequate user interface 1
Detachment of device or device component 1
Difficult to open or close 1
Obstruction within device 1
Failure to calibrate 1
No device output 1
Failure to recalibrate 1
Abnormal 1
Looping 1
Disassembly 1
No display or display failure 1
Problem with software installation 1
Misassembled by Users 1
Patient Data Issue 1
Device handling issue 1
Total Device Problems 642

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 1 0 0 0 0
Class II 0 5 4 6 8 4 0
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Elekta, Inc. II Nov-30-2011
2 Elekta, Inc. II Feb-15-2011
3 Elekta, Inc. II Apr-22-2010
4 FHC, Inc. II Nov-03-2010
5 FHC, Inc. II Dec-22-2008
6 GE OEC Medical Systems, Inc II Jul-11-2012
7 Integra LifeSciences Corp. II Feb-23-2011
8 Integra LifeSciences Corporation II Sep-20-2012
9 Mako Surgical Corporation II Oct-19-2009
10 Mako Surgical Corporation II Feb-11-2009
11 Medtronic Image Guided Neurologics, Inc. II Feb-07-2008
12 Medtronic Navigation, Inc II Oct-03-2011
13 Medtronic Navigation, Inc II Mar-04-2011
14 Medtronic Navigation, Inc II Feb-04-2011
15 Medtronic Navigation, Inc II Dec-17-2010
16 Medtronic Navigation, Inc II Oct-26-2010
17 Medtronic Navigation, Inc II Jul-17-2010
18 Medtronic Navigation, Inc II Mar-03-2010
19 Medtronic Navigation, Inc. II Nov-29-2012
20 Medtronic Navigation, Inc. II Mar-08-2012
21 Medtronic Navigation, Inc. II Jul-11-2011
22 Stryker Instruments Div. of Stryker Corporation I Nov-20-2009
23 Stryker Instruments Div. of Stryker Corporation II Sep-16-2008
24 Stryker Instruments Division of Stryker Corporation II Feb-25-2011
25 Zimmer Inc. II Dec-22-2009
26 Zimmer Inc. II Mar-02-2009
27 Zimmer Inc. II Sep-23-2008
28 Zimmer Inc. II Sep-20-2008

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