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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
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 8
CLEARPOINT NEURO, INC.
  SUBSTANTIALLY EQUIVALENT 3
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA INSTRUMENT AB
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
INTRAVENT MEDICAL PARTNERS, LP
  SUBSTANTIALLY EQUIVALENT 1
LOCALITE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH S.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDTECH S.A.S
  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 3
MRI INTERVENTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
MRI INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NAVINETICS, INC
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH MEDIZINTECHNOLOGIE
  SUBSTANTIALLY EQUIVALENT 2
RENISHAW MAYFIELD SARL
  SUBSTANTIALLY EQUIVALENT 2
SOTERIX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
THERATAXIS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TONICA ELEKTRONIK A/S
  SUBSTANTIALLY EQUIVALENT 1
VOYAGER THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 4439 4439
2019 6062 6062
2020 3480 3480
2021 2830 2830
2022 1938 1938
2023 657 657

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 2996 2996
Human-Device Interface Problem 2811 2811
Material Integrity Problem 2102 2102
Application Program Freezes, Becomes Nonfunctional 2026 2026
Mechanical Problem 1900 1900
Communication or Transmission Problem 1240 1240
Environmental Compatibility Problem 1179 1179
Computer Software Problem 1151 1151
Display or Visual Feedback Problem 996 996
Device Sensing Problem 885 885
Adverse Event Without Identified Device or Use Problem 749 749
Output Problem 693 693
Device Operates Differently Than Expected 593 593
Connection Problem 447 447
Use of Device Problem 424 424
Break 269 269
Electrical /Electronic Property Problem 229 229
Application Interface Becomes Non-Functional Or Program Exits Abnormally 228 228
Material Deformation 165 165
Fracture 151 151
Device Displays Incorrect Message 143 143
No Display/Image 129 129
Device Stops Intermittently 120 120
Application Program Problem 113 113
Mechanical Jam 113 113
Improper or Incorrect Procedure or Method 87 87
Incorrect Measurement 72 72
Computer Operating System Problem 71 71
Insufficient Information 70 70
Unintended Collision 69 69
Disassembly 69 69
Erratic or Intermittent Display 63 63
Image Display Error/Artifact 54 54
Patient Data Problem 54 54
Material Twisted/Bent 46 46
Mechanics Altered 43 43
Unintended Application Program Shut Down 40 40
Device Handling Problem 39 39
Data Problem 38 38
Calibration Problem 37 37
Malposition of Device 36 36
Positioning Problem 34 34
Unintended Movement 33 33
Incorrect, Inadequate or Imprecise Result or Readings 33 33
Failure to Obtain Sample 30 30
Loose or Intermittent Connection 29 29
Excessive Heating 29 29
Device Inoperable 28 28
Device-Device Incompatibility 27 27
Failure to Calibrate 26 26
Intermittent Communication Failure 26 26
Deformation Due to Compressive Stress 23 23
Failure to Power Up 21 21
Bent 21 21
Detachment of Device or Device Component 19 19
Material Fragmentation 18 18
Incorrect Software Programming Calculations 17 17
Image Orientation Incorrect 17 17
Material Separation 17 17
No Device Output 16 16
Protective Measures Problem 16 16
Audible Prompt/Feedback Problem 16 16
Poor Quality Image 15 15
Defective Component 15 15
Appropriate Term/Code Not Available 14 14
Naturally Worn 12 12
Problem with Software Installation 12 12
Component Missing 12 12
Unintended Arm Motion 11 11
Degraded 10 10
Failure to Run on Battery 10 10
Defective Device 10 10
Compatibility Problem 10 10
Temperature Problem 10 10
Intermittent Loss of Power 9 9
Device Difficult to Setup or Prepare 9 9
Delivered as Unsterile Product 9 9
Loss of Data 8 8
Activation, Positioning or Separation Problem 8 8
Failure to Shut Off 7 7
Program or Algorithm Execution Failure 7 7
Physical Resistance/Sticking 6 6
No Apparent Adverse Event 6 6
Electromagnetic Compatibility Problem 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Device Markings/Labelling Problem 6 6
Difficult to Open or Close 6 6
Fitting Problem 6 6
Loss of Power 6 6
Material Frayed 6 6
Product Quality Problem 5 5
Difficult to Remove 5 5
Vibration 5 5
Device Operational Issue 5 5
Biocompatibility 5 5
Device Unsafe to Use in Environment 5 5
Noise, Audible 5 5
Incomplete or Inadequate Connection 4 4
Inadequacy of Device Shape and/or Size 4 4
Device Slipped 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 6081 6081
No Clinical Signs, Symptoms or Conditions 5872 5872
No Known Impact Or Consequence To Patient 5765 5765
No Consequences Or Impact To Patient 1219 1219
Tissue Damage 212 212
No Code Available 182 182
Unspecified Tissue Injury 125 125
Cerebrospinal Fluid Leakage 77 77
Hemorrhage/Bleeding 70 70
Iatrogenic Source 64 64
Insufficient Information 57 57
Unspecified Infection 52 52
Intracranial Hemorrhage 42 42
Hematoma 41 41
Unspecified Nervous System Problem 31 31
Muscle Weakness 29 29
Pain 28 28
Neurological Deficit/Dysfunction 27 27
Device Embedded In Tissue or Plaque 27 27
Post Operative Wound Infection 26 26
Spinal Column Injury 26 26
No Information 23 23
Death 23 23
Hemorrhage, Cerebral 22 22
Dysphasia 20 20
Complaint, Ill-Defined 19 19
Foreign Body In Patient 19 19
Bone Fracture(s) 19 19
Bacterial Infection 18 18
Nerve Damage 15 15
Paresis 15 15
Injury 15 15
Paralysis 14 14
Numbness 13 13
Not Applicable 12 12
Visual Impairment 12 12
Convulsion/Seizure 12 12
Brain Injury 11 11
Cognitive Changes 11 11
Meningitis 11 11
Radiation Exposure, Unintended 10 10
Blood Loss 9 9
Headache 9 9
Burn(s) 8 8
Seizures 8 8
Weakness 7 7
Impaired Healing 7 7
Spinal Cord Injury 7 7
Infarction, Cerebral 7 7
Hydrocephalus 7 7
Thrombosis/Thrombus 6 6
Paresthesia 6 6
Perforation 6 6
Neuropathy 6 6
Loss of Range of Motion 5 5
High Blood Pressure/ Hypertension 5 5
Edema 5 5
Therapeutic Response, Decreased 5 5
Urinary Tract Infection 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Unintended Radiation Exposure 5 5
Swelling/ Edema 5 5
Urinary Retention 4 4
Ambulation Difficulties 4 4
Facial Nerve Paralysis 4 4
Dysphagia/ Odynophagia 4 4
Abscess 4 4
Memory Loss/Impairment 4 4
Low Blood Pressure/ Hypotension 3 3
Hemorrhage, Subdural 3 3
Staphylococcus Aureus 3 3
Myocardial Infarction 3 3
Nausea 3 3
Fever 3 3
Confusion/ Disorientation 3 3
Tissue Breakdown 3 3
Full thickness (Third Degree) Burn 3 3
Burn, Thermal 3 3
Loss of Vision 3 3
Visual Disturbances 3 3
Seroma 3 3
Skin Irritation 3 3
Swelling 3 3
Tachycardia 2 2
Thrombosis 2 2
Blurred Vision 2 2
Electrolyte Imbalance 2 2
Renal Failure 2 2
Dizziness 2 2
Shaking/Tremors 2 2
Paraplegia 2 2
Discomfort 2 2
Encephalitis 2 2
Patient Problem/Medical Problem 2 2
Nervous System Injury 2 2
Emotional Changes 2 2
Pulmonary Emphysema 2 2
Wound Dehiscence 2 2
Erosion 2 2
Bradycardia 2 2

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 Elekta Inc II Apr-29-2020
5 Elekta Instrument AB II Mar-30-2023
6 Elekta Instrument AB II Jul-10-2020
7 FHC, Inc. II Jul-05-2018
8 MEDTECH SAS I Oct-25-2021
9 MEDTECH SAS II Feb-11-2020
10 MEDTECH SAS I Nov-01-2019
11 MEDTECH SAS II Jun-07-2018
12 Mazor Robotics Ltd II Dec-14-2018
13 Medtronic Navigation, Inc. II Jan-30-2023
14 Medtronic Navigation, Inc. I Dec-22-2021
15 Medtronic Navigation, Inc. II Dec-22-2021
16 Medtronic Navigation, Inc. II Jul-27-2020
17 Medtronic Navigation, Inc. I May-18-2020
18 Medtronic Navigation, Inc. II Dec-06-2019
19 Medtronic Navigation, Inc. I Dec-29-2018
20 Medtronic Xomed, Inc. II Oct-21-2021
21 Stryker Instruments Div. of Stryker Corporation II Mar-27-2018
22 Synaptive Medical Inc I Nov-26-2018
23 Zimmer Biomet, Inc. II Feb-16-2018
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