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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
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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