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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 ULC
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 8
CLEARPOINT NEURO INC.
  SUBSTANTIALLY EQUIVALENT 5
CLEARPOINT NEURO, INC.
  SUBSTANTIALLY EQUIVALENT 4
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
INTRAVENT MEDICAL PARTNERS, LP
  SUBSTANTIALLY EQUIVALENT 1
KOH YOUNG TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
LOCALITE GMBH
  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 1
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 3
MRI INTERVENTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
NAVINETICS INC.
  SUBSTANTIALLY EQUIVALENT 1
NAVINETICS, INC
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2
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 1
ZETA SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3480 3480
2021 2827 2827
2022 1930 1930
2023 2515 2515
2024 3760 3760

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 2850 2850
Imprecision 1843 1843
Device Sensing Problem 1742 1742
Application Program Problem 1417 1417
Mechanical Problem 1234 1234
Material Integrity Problem 1110 1110
Display or Visual Feedback Problem 1092 1092
Communication or Transmission Problem 970 970
Human-Device Interface Problem 917 917
Environmental Compatibility Problem 890 890
Incorrect, Inadequate or Imprecise Result or Readings 781 781
Adverse Event Without Identified Device or Use Problem 749 749
Connection Problem 566 566
Use of Device Problem 528 528
Computer Software Problem 330 330
Unexpected Shutdown 295 295
Output Problem 170 170
Incorrect Measurement 160 160
Unintended Application Program Shut Down 123 123
Electrical /Electronic Property Problem 120 120
Power Problem 83 83
Mechanical Jam 81 81
Fracture 79 79
Computer Operating System Problem 74 74
Failure to Power Up 64 64
Break 54 54
Improper or Incorrect Procedure or Method 52 52
Patient Data Problem 51 51
Material Fragmentation 47 47
Mechanics Altered 45 45
Insufficient Information 45 45
No Device Output 41 41
Unintended Collision 38 38
Excessive Heating 38 38
Delayed Program or Algorithm Execution 33 33
Malposition of Device 33 33
Data Problem 32 32
Material Twisted/Bent 32 32
Failure to Read Input Signal 32 32
Activation, Positioning or Separation Problem 30 30
Failure to Shut Off 24 24
Image Display Error/Artifact 23 23
Deformation Due to Compressive Stress 22 22
Material Deformation 19 19
Unintended Movement 18 18
Device-Device Incompatibility 18 18
Audible Prompt/Feedback Problem 16 16
Positioning Problem 15 15
Detachment of Device or Device Component 15 15
Device Handling Problem 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11203 11203
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 214 214
Insufficient Information 113 113
Hemorrhage/Bleeding 95 95
Cerebrospinal Fluid Leakage 69 69
Unspecified Infection 63 63
No Code Available 60 60
Intracranial Hemorrhage 57 57
Tissue Damage 53 53
Unspecified Nervous System Problem 51 51
Hematoma 34 34
Pain 32 32
Muscle Weakness 31 31
Dysphasia 29 29
Post Operative Wound Infection 29 29
Convulsion/Seizure 24 24
Paralysis 19 19
Nerve Damage 18 18
Device Embedded In Tissue or Plaque 17 17
Cognitive Changes 16 16
Foreign Body In Patient 14 14
Bone Fracture(s) 14 14
Bacterial Infection 14 14
Paresis 13 13
Swelling/ Edema 13 13
Thrombosis/Thrombus 13 13
Loss of Range of Motion 12 12
Paresthesia 12 12
Headache 12 12
Numbness 12 12
Meningitis 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
Hydrocephalus 9 9
Visual Impairment 9 9
No Information 9 9
Ambulation Difficulties 9 9
Brain Injury 8 8
Pleural Effusion 8 8
Cardiac Arrest 7 7
Spinal Column Injury 7 7
Perforation 7 7
Abscess 7 7
Urinary Tract Infection 7 7
Unintended Radiation Exposure 7 7
Confusion/ Disorientation 6 6
Spinal Cord Injury 6 6
Visual Disturbances 5 5

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 FHC, Inc. I Nov-08-2024
8 Globus Medical, Inc. II Feb-06-2024
9 MEDTECH SAS I Oct-25-2021
10 MEDTECH SAS II Feb-11-2020
11 Medtronic Navigation, Inc. I May-09-2024
12 Medtronic Navigation, Inc. I Nov-10-2023
13 Medtronic Navigation, Inc. I Jun-02-2023
14 Medtronic Navigation, Inc. I Jun-02-2023
15 Medtronic Navigation, Inc. II Jan-30-2023
16 Medtronic Navigation, Inc. I Dec-22-2021
17 Medtronic Navigation, Inc. II Dec-22-2021
18 Medtronic Navigation, Inc. II Jul-27-2020
19 Medtronic Navigation, Inc. I May-18-2020
20 Medtronic Xomed, Inc. II Oct-21-2021
21 Navinetics Inc II Apr-04-2024
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