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TPLC
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Device
neurological stereotaxic instrument
Product Code
HAW
Regulation Number
882.4560
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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