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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 4
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 2515 2515
2024 885 885

Device Problems MDRs with this Device Problem Events in those MDRs
Human-Device Interface Problem 2598 2598
Imprecision 2479 2479
Application Program Freezes, Becomes Nonfunctional 2422 2422
Material Integrity Problem 1996 1996
Mechanical Problem 1841 1841
Device Sensing Problem 1307 1307
Environmental Compatibility Problem 1217 1217
Display or Visual Feedback Problem 1097 1097
Communication or Transmission Problem 855 855
Adverse Event Without Identified Device or Use Problem 831 831
Computer Software Problem 772 772
Output Problem 593 593
Connection Problem 512 512
Application Program Problem 482 482
Use of Device Problem 480 480
Incorrect, Inadequate or Imprecise Result or Readings 368 368
Incorrect Measurement 163 163
Unexpected Shutdown 163 163
Break 132 132
Electrical /Electronic Property Problem 124 124
Mechanical Jam 105 105
Fracture 90 90
Computer Operating System Problem 76 76
Improper or Incorrect Procedure or Method 67 67
Unintended Application Program Shut Down 63 63
Unintended Collision 55 55
Patient Data Problem 51 51
Insufficient Information 47 47
Mechanics Altered 46 46
Excessive Heating 41 41
Image Display Error/Artifact 39 39
Malposition of Device 37 37
Material Deformation 36 36
Data Problem 35 35
Material Twisted/Bent 33 33
Material Fragmentation 33 33
Deformation Due to Compressive Stress 30 30
Failure to Power Up 29 29
No Device Output 28 28
Detachment of Device or Device Component 24 24
Device-Device Incompatibility 24 24
Power Problem 24 24
Unintended Movement 21 21
Device Handling Problem 21 21
Failure to Calibrate 20 20
Audible Prompt/Feedback Problem 20 20
Calibration Problem 17 17
Activation, Positioning or Separation Problem 17 17
Positioning Problem 17 17
Protective Measures Problem 16 16
Temperature Problem 15 15
Naturally Worn 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
Failure to Shut Off 11 11
Delayed Program or Algorithm Execution 11 11
Intermittent Communication Failure 11 11
Problem with Software Installation 9 9
Defective Device 9 9
Failure to Read Input Signal 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 6 6
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 4 4
Poor Quality Image 4 4
Unintended System Motion 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 8433 8433
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 179 179
Tissue Damage 135 135
No Code Available 134 134
Insufficient Information 97 97
Hemorrhage/Bleeding 93 93
Cerebrospinal Fluid Leakage 71 71
Unspecified Infection 65 65
Intracranial Hemorrhage 48 48
Hematoma 43 43
Unspecified Nervous System Problem 41 41
Pain 31 31
Post Operative Wound Infection 30 30
Dysphasia 29 29
Muscle Weakness 29 29
Device Embedded In Tissue or Plaque 23 23
Iatrogenic Source 21 21
Convulsion/Seizure 20 20
Neurological Deficit/Dysfunction 19 19
Bone Fracture(s) 19 19
Bacterial Infection 19 19
Paresis 18 18
No Information 17 17
Paralysis 16 16
Nerve Damage 16 16
Cognitive Changes 15 15
Foreign Body In Patient 15 15
Complaint, Ill-Defined 14 14
Death 14 14
Numbness 13 13
Hemorrhage, Cerebral 12 12
Thrombosis/Thrombus 12 12
Swelling/ Edema 12 12
Paresthesia 12 12
Headache 11 11
Meningitis 11 11
Visual Impairment 11 11
Loss of Range of Motion 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Radiation Exposure, Unintended 10 10
Impaired Healing 9 9
Brain Injury 9 9
Not Applicable 9 9
Confusion/ Disorientation 8 8
Ambulation Difficulties 8 8
Spinal Cord Injury 8 8
Spinal Column Injury 8 8
Pleural Effusion 8 8
Burn(s) 8 8
Hydrocephalus 8 8
Unintended Radiation Exposure 7 7
Seizures 7 7
Neuropathy 6 6
Memory Loss/Impairment 6 6
High Blood Pressure/ Hypertension 6 6
Abscess 6 6
Urinary Tract Infection 6 6
Weakness 6 6
Visual Disturbances 5 5
Dysphagia/ Odynophagia 5 5
Erosion 5 5
Edema 5 5
Perforation 5 5
Renal Failure 5 5
Infarction, Cerebral 4 4
Pulmonary Emphysema 4 4
Fever 4 4
Urinary Retention 4 4
Seroma 4 4
Tissue Breakdown 4 4
Blood Loss 4 4
Cancer 4 4
Movement Disorder 3 3
Cardiovascular Insufficiency 3 3
Full thickness (Third Degree) Burn 3 3
Respiratory Failure 3 3
Dyskinesia 3 3
Discomfort 3 3
Tachycardia 3 3
Sepsis 3 3
Blurred Vision 3 3
Fistula 3 3
Facial Nerve Paralysis 3 3
Emotional Changes 3 3
Dyspnea 3 3
Staphylococcus Aureus 3 3
Laceration(s) 3 3
Low Blood Pressure/ Hypotension 3 3
Failure of Implant 3 3
Inflammation 3 3
Nausea 3 3
Necrosis 3 3
Myocardial Infarction 2 2
Ischemia 2 2
Oversedation 2 2
Cardiac Arrest 2 2
Stroke/CVA 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 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 Navigation, Inc. II Jul-27-2020
18 Medtronic Navigation, Inc. I May-18-2020
19 Medtronic Navigation, Inc. II Dec-06-2019
20 Medtronic Xomed, Inc. II Oct-21-2021
21 Navinetics Inc II Apr-04-2024
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