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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
7D SURGICAL ULC
  SUBSTANTIALLY EQUIVALENT 1
BAYER MEDICAL CARE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BRAIN NAVI BIOTECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 9
CLARONAV
  SUBSTANTIALLY EQUIVALENT 1
CLEARPOINT NEURO, INC.
  SUBSTANTIALLY EQUIVALENT 10
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
INTRAVENT MEDICAL PARTNERS
  SUBSTANTIALLY EQUIVALENT 1
INTRAVENT MEDICAL PARTNERS, LP
  SUBSTANTIALLY EQUIVALENT 1
KOH YOUNG TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
LOCALITE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDIVIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH S.A
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH S.A.S
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC NAVIGATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 4
MRI INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NAVINETICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2
PHASOR HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
SINOVATION (BEIJING) MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOTERIX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
THERATAXIS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TONICA ELEKTRONIK A/S
  SUBSTANTIALLY EQUIVALENT 1
ZETA SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ZETA SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 3480 3481
2021 2827 2830
2022 1929 1966
2023 2510 2535
2024 3755 3760
2025 3326 3326

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 3007 3021
Mechanical Problem 2532 2534
Device Sensing Problem 2359 2368
Application Program Problem 2357 2364
Imprecision 1867 1886
Display or Visual Feedback Problem 1511 1514
Incorrect, Inadequate or Imprecise Result or Readings 1364 1372
Communication or Transmission Problem 1294 1295
Material Integrity Problem 1116 1122
Human-Device Interface Problem 958 965
Environmental Compatibility Problem 890 892
Adverse Event Without Identified Device or Use Problem 889 892
Use of Device Problem 682 684
Connection Problem 665 665
Computer Software Problem 345 345
Unexpected Shutdown 339 340
Electrical /Electronic Property Problem 186 186
Output Problem 183 184
Incorrect Measurement 161 161
Unintended Application Program Shut Down 143 144
Power Problem 129 129
Mechanical Jam 85 85
Fracture 81 82
Failure to Power Up 76 76
Computer Operating System Problem 74 74
Material Fragmentation 71 71
Insufficient Information 65 66
No Device Output 60 62
Failure to Read Input Signal 57 57
Break 56 57
Improper or Incorrect Procedure or Method 54 54
Delayed Program or Algorithm Execution 52 52
Excessive Heating 51 51
Patient Data Problem 51 51
Mechanics Altered 47 47
Unintended Collision 38 38
Malposition of Device 36 36
Activation, Positioning or Separation Problem 35 35
Data Problem 32 33
Material Twisted/Bent 32 32
Failure to Shut Off 28 28
Naturally Worn 26 26
Image Display Error/Artifact 23 23
Deformation Due to Compressive Stress 22 22
Unintended Movement 20 20
Device Handling Problem 20 20
Material Deformation 19 19
Audible Prompt/Feedback Problem 19 19
Positioning Problem 18 20
Device-Device Incompatibility 18 18

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14415 14477
No Patient Involvement 1449 1449
No Known Impact Or Consequence To Patient 1233 1233
No Consequences Or Impact To Patient 293 293
Unspecified Tissue Injury 234 235
Insufficient Information 153 155
Hemorrhage/Bleeding 109 109
Cerebrospinal Fluid Leakage 74 75
Intracranial Hemorrhage 74 74
Unspecified Infection 70 70
Unspecified Nervous System Problem 60 61
No Code Available 60 60
Tissue Damage 53 53
Pain 41 41
Hematoma 40 40
Muscle Weakness 39 40
Post Operative Wound Infection 32 32
Dysphasia 30 30
Convulsion/Seizure 27 27
Paralysis 22 23
Nerve Damage 21 21
Foreign Body In Patient 20 21
Device Embedded In Tissue or Plaque 18 18
Cognitive Changes 18 19
Paresis 17 18
Bacterial Infection 17 17
Headache 17 17
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 16 16
Numbness 16 17
Swelling/ Edema 16 16
Bone Fracture(s) 16 16
Hydrocephalus 14 14
Paresthesia 13 14
Thrombosis/Thrombus 13 13
Ambulation Difficulties 13 13
Meningitis 12 12
Visual Impairment 12 12
Loss of Range of Motion 12 12
Perforation 10 10
Brain Injury 10 10
No Information 9 9
Cardiac Arrest 8 8
Pleural Effusion 8 8
Abscess 8 8
Memory Loss/Impairment 7 7
Spinal Cord Injury 7 7
Confusion/ Disorientation 7 7
Urinary Tract Infection 7 7
Spinal Column Injury 7 7
Unintended Radiation Exposure 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Brainlab AG II Oct-06-2020
2 Elekta Inc II Apr-29-2020
3 Elekta Instrument AB I Nov-06-2024
4 Elekta Instrument AB I Apr-16-2024
5 Elekta Instrument AB II Mar-30-2023
6 Elekta Instrument AB II Jul-10-2020
7 Elekta, Inc. II Nov-05-2025
8 FHC, Inc. I Nov-08-2024
9 Globus Medical, Inc. II Feb-06-2024
10 MEDTECH SAS I Oct-25-2021
11 MEDTECH SAS II Feb-11-2020
12 Medtronic Navigation, Inc. I May-09-2024
13 Medtronic Navigation, Inc. I Nov-10-2023
14 Medtronic Navigation, Inc. I Jun-02-2023
15 Medtronic Navigation, Inc. I Jun-02-2023
16 Medtronic Navigation, Inc. II Jan-30-2023
17 Medtronic Navigation, Inc. I Dec-22-2021
18 Medtronic Navigation, Inc. II Dec-22-2021
19 Medtronic Navigation, Inc. II Jul-27-2020
20 Medtronic Navigation, Inc. I May-18-2020
21 Medtronic Xomed, Inc. II Oct-21-2021
22 Navinetics Inc II Apr-04-2024
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