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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
Product CodeHAW
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
7D SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
AD-TECH MEDICAL INSTRUMENT CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARC SURGICAL LLC.
  SUBSTANTIALLY EQUIVALENT 1
BLUE ORTHO
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 13
BRAINLAB, AG
  SUBSTANTIALLY EQUIVALENT 1
CLARONAV INC.
  SUBSTANTIALLY EQUIVALENT 1
CLEARPOINT NEURO INC.
  SUBSTANTIALLY EQUIVALENT 5
CLEARPOINT NEURO, INC.
  SUBSTANTIALLY EQUIVALENT 4
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA INSTRUMENT AB
  SUBSTANTIALLY EQUIVALENT 4
FHC, INC.
  SUBSTANTIALLY EQUIVALENT 3
FIAGON GMBH
  SUBSTANTIALLY EQUIVALENT 2
FRED HAER COMPANY, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ILUMARK GMBH
  SUBSTANTIALLY EQUIVALENT 1
IMRIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTRAVENT MEDICAL PARTNERS, LP
  SUBSTANTIALLY EQUIVALENT 1
IZI MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
IZI MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2
KARL STORZ ENDOSCOPY-AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
LOCALITE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MATERIALISE N.V.
  SUBSTANTIALLY EQUIVALENT 1
MAZOR ROBOTICS LTD
  SUBSTANTIALLY EQUIVALENT 3
MAZOR SURGICAL TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL, SA
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH S.A.
  SUBSTANTIALLY EQUIVALENT 5
MEDTECH S.A.S
  SUBSTANTIALLY EQUIVALENT 2
MEDTECH SAS
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 12
MONTERIS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MRI INTERVENTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
MRI INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NAVINETICS INC.
  SUBSTANTIALLY EQUIVALENT 1
NAVINETICS, INC
  SUBSTANTIALLY EQUIVALENT 1
NUCLEMED S.A.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOVITA, INC.
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2
RENISHAW MAYFIELD SARL
  SUBSTANTIALLY EQUIVALENT 3
RENSIHAW PLC
  SUBSTANTIALLY EQUIVALENT 1
SINOVATION (BEIJING) MEDICAL TECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SONOWAND AS
  SUBSTANTIALLY EQUIVALENT 2
SOTERIX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATE
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
STRYKER LEIBINGER GMBH & CO. KG - NAVIGATION
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 4
SYNTHES SPINE
  SUBSTANTIALLY EQUIVALENT 1
TATRAMED SPOL. S.R.O.
  SUBSTANTIALLY EQUIVALENT 1
THERATAXIS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TONICA ELEKTRONIK A/S
  SUBSTANTIALLY EQUIVALENT 1
VOYAGER THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZETA SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ZETA SURGICAL INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 1604 1604
2015 1767 1767
2016 1828 1828
2017 3502 3502
2018 4439 4439
2019 6062 6062
2020 3480 3480
2021 2827 2827
2022 1930 1930
2023 2517 2517
2024 2270 2270

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 5053 5053
Human-Device Interface Problem 2942 2942
Application Program Freezes, Becomes Nonfunctional 2737 2737
Mechanical Problem 2680 2680
Device Operates Differently Than Expected 2260 2260
Material Integrity Problem 2223 2223
Communication or Transmission Problem 2082 2082
Computer Software Problem 1708 1708
Display or Visual Feedback Problem 1551 1551
Device Sensing Problem 1479 1479
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1465 1465
Environmental Compatibility Problem 1317 1317
Adverse Event Without Identified Device or Use Problem 1236 1236
Application Program Problem 1054 1054
Break 882 882
Device Stops Intermittently 850 850
Material Deformation 816 816
Output Problem 729 729
Use of Device Problem 690 690
Incorrect, Inadequate or Imprecise Result or Readings 646 646
Connection Problem 565 565
Device Displays Incorrect Message 527 527
Disassembly 438 438
No Display/Image 436 436
Electrical /Electronic Property Problem 425 425
Unintended Movement 395 395
Unintended Arm Motion 295 295
Unexpected Shutdown 261 261
Fracture 229 229
Device Inoperable 185 185
Incorrect Measurement 171 171
Mechanical Jam 170 170
Improper or Incorrect Procedure or Method 149 149
Erratic or Intermittent Display 147 147
Bent 134 134
Device Issue 128 128
Unintended Application Program Shut Down 122 122
Unintended Collision 107 107
Calibration Problem 105 105
Device Handling Problem 105 105
Computer Operating System Problem 94 94
Insufficient Information 84 84
Naturally Worn 84 84
Positioning Problem 76 76
Failure to Power Up 75 75
Loose or Intermittent Connection 74 74
Image Display Error/Artifact 66 66
Material Fragmentation 66 66
Data Problem 64 64
No Device Output 64 64

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9779 9779
No Patient Involvement 9023 9023
No Known Impact Or Consequence To Patient 6894 6894
No Consequences Or Impact To Patient 5019 5019
Iatrogenic Source 620 620
No Code Available 336 336
Spinal Column Injury 277 277
Tissue Damage 257 257
Unspecified Tissue Injury 208 208
Cerebrospinal Fluid Leakage 135 135
Hemorrhage/Bleeding 127 127
No Information 105 105
Insufficient Information 104 104
Device Embedded In Tissue or Plaque 89 89
Unspecified Infection 85 85
Intracranial Hemorrhage 80 80
Brain Injury 75 75
Injury 71 71
Neurological Deficit/Dysfunction 70 70
Therapeutic Response, Decreased 65 65
Hematoma 60 60
Pain 53 53
Unspecified Nervous System Problem 51 51
Death 48 48
Muscle Weakness 40 40
Foreign Body In Patient 39 39
Post Operative Wound Infection 38 38
Nerve Damage 37 37
Perforation 35 35
Dysphasia 34 34
Paresis 34 34
Paralysis 32 32
Blood Loss 29 29
Visual Impairment 28 28
Hemorrhage, Cerebral 27 27
Bone Fracture(s) 26 26
Convulsion/Seizure 23 23
Numbness 21 21
Complaint, Ill-Defined 20 20
Bacterial Infection 20 20
Cognitive Changes 20 20
Therapeutic Effects, Unexpected 16 16
Meningitis 16 16
Headache 16 16
Not Applicable 15 15
Hydrocephalus 13 13
Swelling/ Edema 13 13
Thrombosis/Thrombus 13 13
Paresthesia 12 12
Loss of Range of Motion 12 12

Recalls
Manufacturer Recall Class Date Posted
1 Brainlab AG II Oct-06-2020
2 Brainlab AG I Apr-15-2019
3 Brainlab AG II Jan-05-2018
4 Brainlab AG I Jan-19-2016
5 Brainlab AG II Nov-17-2015
6 Brainlab AG II Nov-11-2015
7 Brainlab AG II Aug-13-2014
8 Brainlab AG II Apr-17-2014
9 Brainlab AG II Feb-10-2014
10 Elekta Inc II Apr-29-2020
11 Elekta Instrument AB I Apr-16-2024
12 Elekta Instrument AB II Mar-30-2023
13 Elekta Instrument AB II Jul-10-2020
14 Elekta, Inc. II Nov-04-2013
15 Elekta, Inc. II Nov-30-2011
16 Elekta, Inc. II Feb-15-2011
17 Elekta, Inc. II Apr-22-2010
18 FHC, Inc. II Jul-05-2018
19 FHC, Inc. II Nov-03-2010
20 GE OEC Medical Systems, Inc II Jul-11-2012
21 Globus Medical, Inc. II Feb-06-2024
22 Integra LifeSciences Corp. II Oct-06-2015
23 Integra LifeSciences Corp. II Feb-23-2011
24 Integra LifeSciences Corporation II Sep-20-2012
25 MEDTECH SAS I Oct-25-2021
26 MEDTECH SAS II Feb-11-2020
27 MEDTECH SAS I Nov-01-2019
28 MEDTECH SAS II Jun-07-2018
29 Mako Surgical Corporation II Oct-19-2009
30 Mako Surgical Corporation II Feb-11-2009
31 Mazor Robotics Ltd II Dec-14-2018
32 Medtronic Navigation, Inc II Oct-03-2011
33 Medtronic Navigation, Inc II Mar-04-2011
34 Medtronic Navigation, Inc II Feb-04-2011
35 Medtronic Navigation, Inc II Dec-17-2010
36 Medtronic Navigation, Inc II Oct-26-2010
37 Medtronic Navigation, Inc II Jul-17-2010
38 Medtronic Navigation, Inc II Mar-03-2010
39 Medtronic Navigation, Inc. I May-09-2024
40 Medtronic Navigation, Inc. I Nov-10-2023
41 Medtronic Navigation, Inc. I Jun-02-2023
42 Medtronic Navigation, Inc. I Jun-02-2023
43 Medtronic Navigation, Inc. II Jan-30-2023
44 Medtronic Navigation, Inc. I Dec-22-2021
45 Medtronic Navigation, Inc. II Dec-22-2021
46 Medtronic Navigation, Inc. II Jul-27-2020
47 Medtronic Navigation, Inc. I May-18-2020
48 Medtronic Navigation, Inc. II Dec-06-2019
49 Medtronic Navigation, Inc. I Dec-29-2018
50 Medtronic Navigation, Inc. II Jun-26-2017
51 Medtronic Navigation, Inc. II Jan-11-2017
52 Medtronic Navigation, Inc. II Aug-02-2016
53 Medtronic Navigation, Inc. II Mar-24-2016
54 Medtronic Navigation, Inc. II Sep-30-2015
55 Medtronic Navigation, Inc. II Aug-03-2015
56 Medtronic Navigation, Inc. II Jun-26-2015
57 Medtronic Navigation, Inc. II Jun-12-2015
58 Medtronic Navigation, Inc. II May-09-2014
59 Medtronic Navigation, Inc. II Aug-13-2013
60 Medtronic Navigation, Inc. II Nov-29-2012
61 Medtronic Navigation, Inc. II Mar-08-2012
62 Medtronic Navigation, Inc. II Jul-11-2011
63 Medtronic Neuromodulation II Jul-25-2014
64 Medtronic Xomed, Inc. II Oct-21-2021
65 Navinetics Inc II Apr-04-2024
66 Northern Digital Inc. II Jul-16-2015
67 Northern Digital Inc. II Jul-16-2015
68 Orthosoft, Inc. dba Zimmer CAS II Jun-02-2017
69 Orthosoft, Inc. dba Zimmer CAS III May-12-2017
70 Orthosoft, Inc. dba Zimmer CAS II May-12-2017
71 Orthosoft, Inc. dba Zimmer CAS II May-08-2017
72 Stryker Instruments Div. of Stryker Corporation II Mar-27-2018
73 Stryker Instruments Div. of Stryker Corporation II Jun-16-2015
74 Stryker Instruments Div. of Stryker Corporation II Jun-04-2014
75 Stryker Instruments Div. of Stryker Corporation I Nov-20-2009
76 Stryker Instruments Division of Stryker Corporation II Feb-25-2011
77 Synaptive Medical Inc I Nov-26-2018
78 Synaptive Medical, Inc. II Dec-23-2015
79 Zimmer Biomet, Inc. II Feb-16-2018
80 Zimmer Biomet, Inc. II Nov-28-2017
81 Zimmer Biomet, Inc. II Nov-28-2017
82 Zimmer Biomet, Inc. II Nov-21-2017
83 Zimmer Biomet, Inc. II Nov-21-2017
84 Zimmer Biomet, Inc. II Nov-20-2017
85 Zimmer Biomet, Inc. II Nov-18-2017
86 Zimmer Biomet, Inc. II Nov-18-2017
87 Zimmer Biomet, Inc. II Nov-17-2017
88 Zimmer Biomet, Inc. II Nov-16-2017
89 Zimmer Biomet, Inc. II Nov-16-2017
90 Zimmer Biomet, Inc. II Nov-16-2017
91 Zimmer Biomet, Inc. II Nov-16-2017
92 Zimmer Biomet, Inc. II Sep-12-2017
93 Zimmer Biomet, Inc. II Aug-03-2017
94 Zimmer Biomet, Inc. II Mar-27-2017
95 Zimmer Inc. II Dec-22-2009
96 Zimmer Inc. II Mar-02-2009
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