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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 8
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.S
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC NAVIGATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 4
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
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 3

MDR Year MDR Reports MDR Events
2021 2827 2830
2022 1929 1966
2023 2510 2535
2024 3755 3760
2025 3484 3484
2026 787 787

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes or Fails to Launch 2640 2654
Application Program Problem 2535 2542
Mechanical Problem 2368 2370
Device Sensing Problem 2331 2340
Incorrect, Inadequate or Imprecise Result or Readings 1626 1634
Display or Visual Feedback Problem 1400 1403
Imprecision 1379 1398
Communication or Transmission Problem 1072 1073
Adverse Event Without Identified Device or Use Problem 804 807
Material Integrity Problem 776 782
Environmental Compatibility Problem 651 653
Use of Device Problem 621 623
Connection Problem 557 557
Human-Device Interface Problem 470 477
Unexpected Shutdown 347 348
Electrical /Electronic Property Problem 215 215
Computer Software Problem 181 181
Incorrect Measurement 161 161
Unintended Application Program Shut Down 145 146
Power Problem 140 140
Output Problem 85 86
Material Fragmentation 83 83
Failure to Power Up 78 78
No Device Output 69 71
Activation, Positioning or Separation Problem 63 63
Fracture 62 63
Failure to Read Input Signal 62 62
Delayed Program or Algorithm Execution 57 57
Computer Operating System Problem 57 57
Excessive Heating 50 50
Insufficient Device Problem Information 47 48
Mechanical Jam 40 40
Naturally Worn 37 37
Improper or Incorrect Procedure or Method 37 37
Mechanics Altered 35 35
Break 32 32
Patient Data Problem 31 31
Failure to Shut Off 30 30
Malposition of Device 23 23
Data Problem 23 24
Positioning Problem 22 22
Material Twisted/Bent 22 22
Deformation Due to Compressive Stress 21 21
Audible Prompt/Feedback Problem 20 20
Device Handling Problem 18 18
Unintended Movement 17 17
Unintended Collision 16 16
Overheating of Device 15 15
Detachment of Device or Device Component 14 14
Component Missing 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14513 14575
Unspecified Tissue Injury 226 227
Insufficient Information 157 159
Hemorrhage/Blood Loss/Bleeding 100 100
Intracranial Hemorrhage 73 73
Unspecified Nervous System Problem 70 71
Cerebrospinal Fluid Leakage 67 68
Unspecified Infection 63 63
No Consequences Or Impact To Patient 48 48
Hematoma 39 39
Muscle Weakness/Atrophy 38 39
Pain 35 35
Dysphasia 33 33
Convulsion/Seizure 29 29
Post Operative Wound Infection 28 28
Paralysis 26 27
Cognitive Changes 22 23
No Patient Involvement 20 20
Swelling/ Edema 19 19
Paresis 19 20
Headache 19 19
Nerve Damage 18 18
Ambulation or Postural Difficulties 17 17
Hydrocephalus 16 16
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 16 16
Foreign Body In Patient 16 16
Bacterial Infection 16 16
Numbness 15 16
Paresthesia 13 14
Thrombosis/Thrombus 13 13
Bone Fracture(s) 12 12
Loss of Range of Motion 12 12
Device Embedded In Tissue or Plaque 11 11
Visual Impairment 11 11
Meningitis 11 11
Memory Loss/Impairment 10 10
Facial Paralysis 10 10
Perforation 9 9
Brain Injury 8 8
Cardiac Arrest 8 8
Pleural Effusion 8 8
Urinary Tract Infection 7 7
Unintended Radiation Exposure 7 7
Fever 7 7
Spinal Column Injury 7 7
Respiratory Tract Infection 7 7
Confusion/ Disorientation 7 7
Abscess 7 7
Cancer 7 8
Sepsis 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Elekta Instrument AB I Nov-06-2024
2 Elekta Instrument AB I Apr-16-2024
3 Elekta Instrument AB II Mar-30-2023
4 Elekta, Inc. II Apr-29-2026
5 Elekta, Inc. II Nov-05-2025
6 FHC, Inc. I Nov-08-2024
7 Globus Medical, Inc. II Feb-06-2024
8 Howmedica Osteonics Corp. II Dec-19-2025
9 MEDTECH SAS I Oct-25-2021
10 Medtronic Navigation, Inc. I May-09-2024
11 Medtronic Navigation, Inc. I Nov-10-2023
12 Medtronic Navigation, Inc. I Jun-02-2023
13 Medtronic Navigation, Inc. I Jun-02-2023
14 Medtronic Navigation, Inc. II Jan-30-2023
15 Medtronic Navigation, Inc. I Dec-22-2021
16 Medtronic Navigation, Inc. II Dec-22-2021
17 Medtronic Xomed, Inc. II Oct-21-2021
18 Navinetics Inc II Apr-04-2024
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