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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 15
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 16
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 1309
Device operates differently than expected 1238
Application interface becomes non-functional or program exits abnormally 860
Device stops intermittently 590
Communication or transmission issue 569
Material deformation 569
Computer software issue 462
Break 335
Device displays error message 312
Disassembly 295
Unintended movement 281
Mechanical issue 253
No display or display failure 249
Unintended arm motion 221
No Known Device Problem 188
Incorrect display 156
Device inoperable 134
Electrical issue 121
Use of Device Issue 98
Bent 83
Erratic display 72
Naturally worn 63
Fracture 60
Calibration issue 59
Device handling issue 57
Device Issue 56
Improper or incorrect procedure or method 52
Mechanical jam 36
Unstable 35
Loose or intermittent connection 31
Unintended collision 27
Image reversal 21
Device clogged 19
Slippage of device or device component 18
Degraded 17
Data Issue 17
Material twisted 15
No device output 15
Component missing 14
Connection issue 14
Computer operating system issue 13
Device emits odor 13
Material fragmentation 13
Poor quality image 12
Improper device output 12
Difficult to position 10
Device Cleaning Issue 10
Positioning Issue 10
Detachment of device component 9
Device Difficult to Setup or Prepare 9
Failure to calibrate 9
Defective component 9
Application program issue 8
Occlusion within device 8
Difficult to deploy 8
Image display error 7
Incorrect or inadequate result 7
Misconnection 6
Mislocation 6
Image orientation incorrect 6
Material frayed 6
Burn of device or device component 6
Device, removal of (non-implant) 6
Device or device component damaged by another device 6
Device sensing issue 6
No Information 6
No code available 6
Operating system becomes non-functional 5
Human-Device Interface Issue 5
Spark 5
Detachment of device or device component 5
Invalid sensing 5
Other (for use when an appropriate device code cannot be identified) 5
Tip breakage 5
Interference 5
Device, or device fragments remain in patient 5
Misassembled 4
Difficult to flush 4
Disconnection 4
Failure to Adhere or Bond 4
Stretched 4
Loss of Data 4
Patient-device incompatibility 4
Dislodged or dislocated 4
Difficult to open or close 4
Output issue 4
Scratched material 4
Misassembled by Users 4
Optical issue 3
Manufacturing or shipping issue associated with device 3
Material Distortion 3
Device misassembled during manufacturing or shipping 3
Suction issue 3
Fitting problem 3
Failure to align 3
Failure to obtain samples 3
Loss of or failure to bond 3
Intermittent continuity 3
Incorrect measurement 3
Device abrasion from instrument or another object 3
Total Device Problems 9377

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 8
Class III 0 0 0 0 0 0 0 0 0 0 1

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 Jun-26-2017
28 Medtronic Navigation, Inc. II Jan-11-2017
29 Medtronic Navigation, Inc. II Aug-02-2016
30 Medtronic Navigation, Inc. II Mar-24-2016
31 Medtronic Navigation, Inc. II Sep-30-2015
32 Medtronic Navigation, Inc. II Aug-03-2015
33 Medtronic Navigation, Inc. II Jun-26-2015
34 Medtronic Navigation, Inc. II Jun-12-2015
35 Medtronic Navigation, Inc. II May-09-2014
36 Medtronic Navigation, Inc. II Aug-13-2013
37 Medtronic Navigation, Inc. II Nov-29-2012
38 Medtronic Navigation, Inc. II Mar-08-2012
39 Medtronic Navigation, Inc. II Jul-11-2011
40 Medtronic Neuromodulation II Jul-25-2014
41 Northern Digital Inc. II Jul-16-2015
42 Northern Digital Inc. II Jul-16-2015
43 Orthosoft, Inc. dba Zimmer CAS II Jun-02-2017
44 Orthosoft, Inc. dba Zimmer CAS III May-12-2017
45 Orthosoft, Inc. dba Zimmer CAS II May-12-2017
46 Orthosoft, Inc. dba Zimmer CAS II May-08-2017
47 Stryker Instruments Div. of Stryker Corporation II Jun-16-2015
48 Stryker Instruments Div. of Stryker Corporation II Jun-04-2014
49 Stryker Instruments Div. of Stryker Corporation I Nov-20-2009
50 Stryker Instruments Div. of Stryker Corporation II Sep-16-2008
51 Stryker Instruments Division of Stryker Corporation II Feb-25-2011
52 Synaptive Medical, Inc. II Dec-23-2015
53 Zimmer Biomet, Inc. II Sep-12-2017
54 Zimmer Biomet, Inc. II Aug-03-2017
55 Zimmer Biomet, Inc. II Mar-27-2017
56 Zimmer Inc. II Dec-22-2009
57 Zimmer Inc. II Mar-02-2009
58 Zimmer Inc. II Sep-23-2008
59 Zimmer Inc. II Sep-20-2008

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