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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 7
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
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 1
RENISHAW MAYFIELD SARL
  SUBSTANTIALLY EQUIVALENT 2
SOTERIX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
THERATAXIS, LLC
  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 1926 1926

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 2853 2853
Human-Device Interface Problem 2766 2766
Material Integrity Problem 2022 2022
Mechanical Problem 1895 1895
Application Program Freezes, Becomes Nonfunctional 1836 1836
Communication or Transmission Problem 1210 1210
Computer Software Problem 1142 1142
Environmental Compatibility Problem 1098 1098
Display or Visual Feedback Problem 979 979
Device Sensing Problem 782 782
Adverse Event Without Identified Device or Use Problem 705 705
Output Problem 682 682
Device Operates Differently Than Expected 593 593
Connection Problem 424 424
Use of Device Problem 404 404
Break 264 264
Application Interface Becomes Non-Functional Or Program Exits Abnormally 228 228
Electrical /Electronic Property Problem 221 221
Material Deformation 165 165
Fracture 148 148
Device Displays Incorrect Message 143 143
No Display/Image 129 129
Device Stops Intermittently 120 120
Application Program Problem 113 113
Mechanical Jam 111 111
Improper or Incorrect Procedure or Method 80 80
Unintended Collision 69 69
Disassembly 69 69
Computer Operating System Problem 68 68
Insufficient Information 67 67
Erratic or Intermittent Display 63 63
Patient Data Problem 54 54
Image Display Error/Artifact 54 54
Material Twisted/Bent 42 42
Incorrect Measurement 41 41
Mechanics Altered 40 40
Unintended Application Program Shut Down 40 40
Device Handling Problem 38 38
Data Problem 37 37
Calibration Problem 37 37
Malposition of Device 36 36
Unintended Movement 33 33
Positioning Problem 31 31
Failure to Obtain Sample 30 30
Excessive Heating 29 29
Device Inoperable 28 28
Loose or Intermittent Connection 28 28
Incorrect, Inadequate or Imprecise Result or Readings 28 28
Failure to Calibrate 26 26
Intermittent Communication Failure 25 25
Device-Device Incompatibility 24 24
Bent 21 21
Failure to Power Up 21 21
Deformation Due to Compressive Stress 19 19
Detachment of Device or Device Component 18 18
Image Orientation Incorrect 17 17
Material Separation 17 17
Incorrect Software Programming Calculations 17 17
Material Fragmentation 17 17
Protective Measures Problem 16 16
Audible Prompt/Feedback Problem 16 16
Defective Component 15 15
Poor Quality Image 15 15
No Device Output 14 14
Appropriate Term/Code Not Available 13 13
Naturally Worn 12 12
Component Missing 12 12
Problem with Software Installation 12 12
Unintended Arm Motion 11 11
Failure to Run on Battery 10 10
Delivered as Unsterile Product 9 9
Degraded 9 9
Device Difficult to Setup or Prepare 9 9
Temperature Problem 9 9
Intermittent Loss of Power 9 9
Compatibility Problem 9 9
Loss of Data 8 8
Defective Device 8 8
Failure to Shut Off 7 7
Program or Algorithm Execution Failure 7 7
Loss of Power 6 6
Fitting Problem 6 6
Physical Resistance/Sticking 6 6
No Apparent Adverse Event 6 6
Difficult to Open or Close 6 6
Device Markings/Labelling Problem 6 6
Electromagnetic Compatibility Problem 6 6
Material Frayed 6 6
Manufacturing, Packaging or Shipping Problem 6 6
Biocompatibility 5 5
Device Unsafe to Use in Environment 5 5
Product Quality Problem 5 5
Difficult to Remove 5 5
Device Operational Issue 5 5
Positioning Failure 4 4
Inadequacy of Device Shape and/or Size 4 4
Vibration 4 4
Incomplete or Inadequate Connection 4 4
Entrapment of Device 4 4
Insufficient Cooling 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 6081 6081
No Known Impact Or Consequence To Patient 5765 5765
No Clinical Signs, Symptoms or Conditions 5241 5241
No Consequences Or Impact To Patient 1219 1219
Tissue Damage 212 212
No Code Available 182 182
Unspecified Tissue Injury 109 109
Cerebrospinal Fluid Leakage 72 72
Hemorrhage/Bleeding 66 66
Iatrogenic Source 64 64
Unspecified Infection 47 47
Insufficient Information 44 44
Intracranial Hemorrhage 39 39
Hematoma 38 38
Neurological Deficit/Dysfunction 27 27
Unspecified Nervous System Problem 27 27
Device Embedded In Tissue or Plaque 27 27
Muscle Weakness 26 26
Spinal Column Injury 25 25
Pain 23 23
Death 23 23
No Information 23 23
Hemorrhage, Cerebral 22 22
Post Operative Wound Infection 21 21
Complaint, Ill-Defined 19 19
Foreign Body In Patient 19 19
Bone Fracture(s) 18 18
Dysphasia 18 18
Injury 15 15
Bacterial Infection 15 15
Nerve Damage 14 14
Paralysis 14 14
Paresis 13 13
Not Applicable 12 12
Visual Impairment 12 12
Brain Injury 11 11
Convulsion/Seizure 11 11
Radiation Exposure, Unintended 10 10
Numbness 10 10
Cognitive Changes 9 9
Blood Loss 9 9
Meningitis 9 9
Burn(s) 8 8
Seizures 8 8
Headache 8 8
Weakness 7 7
Impaired Healing 7 7
Spinal Cord Injury 7 7
Infarction, Cerebral 7 7
Hydrocephalus 6 6
Perforation 6 6
Neuropathy 6 6
Paresthesia 6 6
High Blood Pressure/ Hypertension 5 5
Edema 5 5
Therapeutic Response, Decreased 5 5
Unintended Radiation Exposure 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Thrombosis/Thrombus 4 4
Urinary Tract Infection 4 4
Swelling/ Edema 4 4
Memory Loss/Impairment 4 4
Abscess 4 4
Facial Nerve Paralysis 4 4
Hemorrhage, Subdural 3 3
Burn, Thermal 3 3
Tissue Breakdown 3 3
Full thickness (Third Degree) Burn 3 3
Staphylococcus Aureus 3 3
Skin Irritation 3 3
Ambulation Difficulties 3 3
Urinary Retention 3 3
Loss of Vision 3 3
Confusion/ Disorientation 3 3
Myocardial Infarction 3 3
Nausea 3 3
Swelling 3 3
Thrombosis 2 2
Speech Disorder 2 2
Pulmonary Embolism 2 2
Loss of Range of Motion 2 2
Renal Failure 2 2
Inflammation 2 2
Seroma 2 2
Bradycardia 2 2
Stroke/CVA 2 2
Patient Problem/Medical Problem 2 2
Nervous System Injury 2 2
Blurred Vision 2 2
Visual Disturbances 2 2
Fever 2 2
Hemorrhage, Extradural 2 2
Dysphagia/ Odynophagia 2 2
Wound Dehiscence 2 2
Oversedation 2 2
Failure of Implant 2 2
Laceration(s) 2 2
Encephalitis 2 2
Dizziness 2 2
Paraplegia 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 Jul-10-2020
6 FHC, Inc. II Jul-05-2018
7 MEDTECH SAS I Oct-25-2021
8 MEDTECH SAS II Feb-11-2020
9 MEDTECH SAS I Nov-01-2019
10 MEDTECH SAS II Jun-07-2018
11 Mazor Robotics Ltd II Dec-14-2018
12 Medtronic Navigation, Inc. I Dec-22-2021
13 Medtronic Navigation, Inc. II Dec-22-2021
14 Medtronic Navigation, Inc. II Jul-27-2020
15 Medtronic Navigation, Inc. I May-18-2020
16 Medtronic Navigation, Inc. II Dec-06-2019
17 Medtronic Navigation, Inc. I Dec-29-2018
18 Medtronic Xomed, Inc. II Oct-21-2021
19 Stryker Instruments Div. of Stryker Corporation II Mar-27-2018
20 Synaptive Medical Inc I Nov-26-2018
21 Zimmer Biomet, Inc. II Feb-16-2018
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