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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 2513 2513
2024 371 371

Device Problems MDRs with this Device Problem Events in those MDRs
Human-Device Interface Problem 2598 2598
Imprecision 2476 2476
Application Program Freezes, Becomes Nonfunctional 2371 2371
Material Integrity Problem 1995 1995
Mechanical Problem 1765 1765
Device Sensing Problem 1247 1247
Environmental Compatibility Problem 1217 1217
Display or Visual Feedback Problem 1035 1035
Communication or Transmission Problem 844 844
Adverse Event Without Identified Device or Use Problem 793 793
Computer Software Problem 763 763
Output Problem 593 593
Connection Problem 500 500
Use of Device Problem 459 459
Application Program Problem 329 329
Incorrect, Inadequate or Imprecise Result or Readings 269 269
Incorrect Measurement 160 160
Break 131 131
Electrical /Electronic Property Problem 118 118
Unexpected Shutdown 109 109
Mechanical Jam 104 104
Fracture 87 87
Computer Operating System Problem 76 76
Improper or Incorrect Procedure or Method 67 67
Unintended Collision 54 54
Patient Data Problem 51 51
Unintended Application Program Shut Down 48 48
Insufficient Information 46 46
Mechanics Altered 46 46
Image Display Error/Artifact 39 39
Excessive Heating 39 39
Malposition of Device 37 37
Material Deformation 35 35
Data Problem 35 35
Material Twisted/Bent 32 32
Deformation Due to Compressive Stress 30 30
Material Fragmentation 26 26
No Device Output 24 24
Device-Device Incompatibility 24 24
Detachment of Device or Device Component 23 23
Unintended Movement 21 21
Device Handling Problem 20 20
Failure to Calibrate 20 20
Audible Prompt/Feedback Problem 19 19
Power Problem 19 19
Failure to Power Up 19 19
Positioning Problem 17 17
Calibration Problem 17 17
Protective Measures Problem 16 16
Temperature Problem 15 15
Material Separation 14 14
Loose or Intermittent Connection 14 14
Naturally Worn 13 13
Degraded 12 12
Defective Component 11 11
Failure to Shut Off 11 11
Compatibility Problem 11 11
Appropriate Term/Code Not Available 11 11
Activation, Positioning or Separation Problem 11 11
Intermittent Communication Failure 11 11
Delayed Program or Algorithm Execution 9 9
Defective Device 9 9
Problem with Software Installation 9 9
Delivered as Unsterile Product 9 9
Failure to Read Input Signal 8 8
Program or Algorithm Execution Failure 8 8
Failure to Run on Battery 7 7
Electromagnetic Compatibility Problem 7 7
Loss of Data 6 6
Device Displays Incorrect Message 6 6
No Display/Image 6 6
Product Quality Problem 5 5
Component Missing 5 5
Fitting Problem 5 5
Vibration 5 5
Device Markings/Labelling Problem 5 5
Device Unsafe to Use in Environment 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Noise, Audible 5 5
Physical Resistance/Sticking 5 5
No Apparent Adverse Event 4 4
Biocompatibility 4 4
Inadequacy of Device Shape and/or Size 4 4
Failure to Transmit Record 4 4
Unintended System Motion 4 4
Poor Quality Image 4 4
Insufficient Cooling 4 4
Incomplete or Inadequate Connection 4 4
Intermittent Program or Algorithm Execution 4 4
Inaccurate Information 3 3
Device Alarm System 3 3
Positioning Failure 3 3
Material Discolored 3 3
Flaked 3 3
Image Orientation Incorrect 3 3
Misconnection 3 3
Difficult to Remove 3 3
Device Slipped 3 3
Unstable 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 7955 7955
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 165 165
Tissue Damage 135 135
No Code Available 134 134
Insufficient Information 90 90
Hemorrhage/Bleeding 82 82
Cerebrospinal Fluid Leakage 68 68
Unspecified Infection 61 61
Intracranial Hemorrhage 46 46
Hematoma 42 42
Unspecified Nervous System Problem 41 41
Pain 29 29
Post Operative Wound Infection 28 28
Muscle Weakness 27 27
Dysphasia 26 26
Device Embedded In Tissue or Plaque 23 23
Iatrogenic Source 21 21
Neurological Deficit/Dysfunction 19 19
Convulsion/Seizure 19 19
Paresis 18 18
Bacterial Infection 18 18
Bone Fracture(s) 18 18
No Information 17 17
Nerve Damage 16 16
Cognitive Changes 15 15
Foreign Body In Patient 14 14
Complaint, Ill-Defined 14 14
Paralysis 14 14
Death 14 14
Numbness 13 13
Hemorrhage, Cerebral 12 12
Swelling/ Edema 12 12
Paresthesia 11 11
Thrombosis/Thrombus 11 11
Meningitis 11 11
Radiation Exposure, Unintended 10 10
Visual Impairment 10 10
Headache 10 10
Loss of Range of Motion 10 10
Brain Injury 9 9
Not Applicable 9 9
Impaired Healing 8 8
Spinal Column Injury 8 8
Hydrocephalus 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Spinal Cord Injury 7 7
Seizures 7 7
Burn(s) 7 7
Neuropathy 6 6
Memory Loss/Impairment 6 6
High Blood Pressure/ Hypertension 6 6
Ambulation Difficulties 6 6
Confusion/ Disorientation 6 6
Weakness 6 6
Unintended Radiation Exposure 6 6
Visual Disturbances 5 5
Urinary Tract Infection 5 5
Edema 5 5
Infarction, Cerebral 4 4
Fever 4 4
Abscess 4 4
Dysphagia/ Odynophagia 4 4
Perforation 4 4
Seroma 4 4
Urinary Retention 4 4
Blood Loss 4 4
Tissue Breakdown 4 4
Cancer 4 4
Full thickness (Third Degree) Burn 3 3
Dyskinesia 3 3
Discomfort 3 3
Tachycardia 3 3
Blurred Vision 3 3
Renal Failure 3 3
Staphylococcus Aureus 3 3
Nausea 3 3
Low Blood Pressure/ Hypotension 3 3
Failure of Implant 3 3
Laceration(s) 3 3
Inflammation 3 3
Dyspnea 3 3
Facial Nerve Paralysis 3 3
Emotional Changes 3 3
Pulmonary Emphysema 3 3
Movement Disorder 3 3
Speech Disorder 2 2
Partial Hearing Loss 2 2
Syncope/Fainting 2 2
Cardiovascular Insufficiency 2 2
Hemorrhage, Extradural 2 2
Cardiac Arrest 2 2
Stroke/CVA 2 2
Erosion 2 2
Bradycardia 2 2
Bruise/Contusion 2 2
Wound Dehiscence 2 2
Pulmonary Embolism 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 II Mar-30-2023
5 Elekta Instrument AB II Jul-10-2020
6 Globus Medical, Inc. II Feb-06-2024
7 MEDTECH SAS I Oct-25-2021
8 MEDTECH SAS II Feb-11-2020
9 MEDTECH SAS I Nov-01-2019
10 Medtronic Navigation, Inc. I Nov-10-2023
11 Medtronic Navigation, Inc. I Jun-02-2023
12 Medtronic Navigation, Inc. I Jun-02-2023
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 Xomed, Inc. II Oct-21-2021
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