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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 2
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 9
CLEARPOINT NEURO INC.
  SUBSTANTIALLY EQUIVALENT 5
CLEARPOINT NEURO, INC.
  SUBSTANTIALLY EQUIVALENT 4
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 2
MEDTECH S.A.S
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC NAVIGATION
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 4
MRI INTERVENTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
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
SYNAPTIVE MEDICAL INC.
  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

MDR Year MDR Reports MDR Events
2019 6062 6062
2020 3480 3480
2021 2827 2827
2022 1930 1930
2023 2517 2517
2024 1480 1480

Device Problems MDRs with this Device Problem Events in those MDRs
Human-Device Interface Problem 2598 2598
Application Program Freezes, Becomes Nonfunctional 2490 2490
Imprecision 2482 2482
Material Integrity Problem 1996 1996
Mechanical Problem 1931 1931
Device Sensing Problem 1369 1369
Environmental Compatibility Problem 1217 1217
Display or Visual Feedback Problem 1152 1152
Communication or Transmission Problem 870 870
Adverse Event Without Identified Device or Use Problem 854 854
Computer Software Problem 779 779
Application Program Problem 654 654
Output Problem 593 593
Connection Problem 525 525
Incorrect, Inadequate or Imprecise Result or Readings 522 522
Use of Device Problem 498 498
Unexpected Shutdown 226 226
Incorrect Measurement 164 164
Electrical /Electronic Property Problem 133 133
Break 132 132
Mechanical Jam 106 106
Fracture 94 94
Unintended Application Program Shut Down 92 92
Computer Operating System Problem 76 76
Improper or Incorrect Procedure or Method 67 67
Unintended Collision 55 55
Patient Data Problem 51 51
Insufficient Information 48 48
Mechanics Altered 46 46
Excessive Heating 43 43
Material Fragmentation 41 41
Image Display Error/Artifact 39 39
Failure to Power Up 38 38
Malposition of Device 37 37
Material Deformation 36 36
Data Problem 36 36
Power Problem 33 33
Material Twisted/Bent 33 33
No Device Output 33 33
Deformation Due to Compressive Stress 30 30
Detachment of Device or Device Component 25 25
Device-Device Incompatibility 24 24
Unintended Movement 21 21
Device Handling Problem 21 21
Audible Prompt/Feedback Problem 21 21
Activation, Positioning or Separation Problem 20 20
Failure to Calibrate 20 20
Calibration Problem 17 17
Positioning Problem 17 17
Naturally Worn 17 17
Failure to Read Input Signal 17 17
Failure to Shut Off 16 16
Protective Measures Problem 16 16
Temperature Problem 16 16
Delayed Program or Algorithm Execution 15 15
Material Separation 14 14
Loose or Intermittent Connection 14 14
Appropriate Term/Code Not Available 13 13
Degraded 12 12
Defective Component 12 12
Compatibility Problem 11 11
Intermittent Communication Failure 11 11
Problem with Software Installation 9 9
Defective Device 9 9
Delivered as Unsterile Product 9 9
Electromagnetic Compatibility Problem 8 8
Program or Algorithm Execution Failure 8 8
Failure to Run on Battery 7 7
Component Missing 7 7
Fitting Problem 6 6
No Display/Image 6 6
Device Displays Incorrect Message 6 6
Loss of Data 6 6
Device Markings/Labelling Problem 5 5
Device Unsafe to Use in Environment 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Physical Resistance/Sticking 5 5
Noise, Audible 5 5
Vibration 5 5
Product Quality Problem 5 5
Failure to Transmit Record 5 5
Unintended System Motion 5 5
Poor Quality Image 4 4
Inadequacy of Device Shape and/or Size 4 4
Insufficient Cooling 4 4
No Apparent Adverse Event 4 4
Biocompatibility 4 4
Incomplete or Inadequate Connection 4 4
Intermittent Program or Algorithm Execution 4 4
Inaccurate Information 3 3
Unstable 3 3
Device Alarm System 3 3
Positioning Failure 3 3
Material Discolored 3 3
Image Orientation Incorrect 3 3
Flaked 3 3
Device Slipped 3 3
Misconnection 3 3
Difficult to Remove 3 3
Shipping Damage or Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9013 9013
No Patient Involvement 4337 4337
No Known Impact Or Consequence To Patient 3858 3858
No Consequences Or Impact To Patient 609 609
Unspecified Tissue Injury 193 193
Tissue Damage 135 135
No Code Available 134 134
Insufficient Information 101 101
Hemorrhage/Bleeding 97 97
Cerebrospinal Fluid Leakage 73 73
Unspecified Infection 68 68
Intracranial Hemorrhage 49 49
Unspecified Nervous System Problem 47 47
Hematoma 45 45
Pain 33 33
Post Operative Wound Infection 33 33
Muscle Weakness 31 31
Dysphasia 30 30
Device Embedded In Tissue or Plaque 25 25
Convulsion/Seizure 21 21
Iatrogenic Source 21 21
Nerve Damage 20 20
Bacterial Infection 20 20
Bone Fracture(s) 19 19
Neurological Deficit/Dysfunction 19 19
Paresis 18 18
No Information 17 17
Paralysis 16 16
Cognitive Changes 16 16
Foreign Body In Patient 15 15
Numbness 14 14
Complaint, Ill-Defined 14 14
Death 14 14
Swelling/ Edema 13 13
Paresthesia 12 12
Thrombosis/Thrombus 12 12
Headache 12 12
Loss of Range of Motion 12 12
Hemorrhage, Cerebral 12 12
Meningitis 12 12
Brain Injury 11 11
Visual Impairment 11 11
Radiation Exposure, Unintended 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Ambulation Difficulties 9 9
Not Applicable 9 9
Hydrocephalus 9 9
Impaired Healing 9 9
Confusion/ Disorientation 8 8
Spinal Cord Injury 8 8
Pleural Effusion 8 8
Spinal Column Injury 8 8
Burn(s) 8 8
Neuropathy 7 7
Seizures 7 7
Urinary Tract Infection 7 7
Unintended Radiation Exposure 7 7
Weakness 6 6
High Blood Pressure/ Hypertension 6 6
Memory Loss/Impairment 6 6
Abscess 6 6
Dysphagia/ Odynophagia 5 5
Erosion 5 5
Edema 5 5
Pulmonary Emphysema 5 5
Renal Failure 5 5
Perforation 5 5
Visual Disturbances 5 5
Seroma 4 4
Blood Loss 4 4
Tissue Breakdown 4 4
Urinary Retention 4 4
Infarction, Cerebral 4 4
Fever 4 4
Dyspnea 4 4
Cancer 4 4
Cardiovascular Insufficiency 3 3
Movement Disorder 3 3
Fistula 3 3
Facial Nerve Paralysis 3 3
Emotional Changes 3 3
Cardiac Arrest 3 3
Staphylococcus Aureus 3 3
Nausea 3 3
Necrosis 3 3
Laceration(s) 3 3
Inflammation 3 3
Low Blood Pressure/ Hypotension 3 3
Failure of Implant 3 3
Discomfort 3 3
Dyskinesia 3 3
Full thickness (Third Degree) Burn 3 3
Respiratory Failure 3 3
Sepsis 3 3
Blurred Vision 3 3
Tachycardia 3 3
Thrombosis 2 2
Skin Irritation 2 2
Swelling 2 2
Vomiting 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Brainlab AG II Oct-06-2020
2 Brainlab AG I Apr-15-2019
3 Elekta Inc II Apr-29-2020
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 Globus Medical, Inc. II Feb-06-2024
8 MEDTECH SAS I Oct-25-2021
9 MEDTECH SAS II Feb-11-2020
10 MEDTECH SAS I Nov-01-2019
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 Navigation, Inc. II Dec-06-2019
21 Medtronic Xomed, Inc. II Oct-21-2021
22 Navinetics Inc II Apr-04-2024
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