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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
Regulation Description Stereotaxic instrument.
Product CodeHAW
Regulation Number 882.4560
Device Class 2


Premarket Reviews
ManufacturerDecision
7D SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
BLUE ORTHO
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 6
CLARONAV INC.
  SUBSTANTIALLY EQUIVALENT 1
CLEARPOINT NEURO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA INSTRUMENT AB
  SUBSTANTIALLY EQUIVALENT 3
FIAGON GMBH
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTRAVENT MEDICAL PARTNERS, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDTECH S.A.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC NAVIGATION INC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION, INC.
  SUBSTANTIALLY EQUIVALENT 6
MRI INTERVENTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
MRI INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NAVINETICS, INC
  SUBSTANTIALLY EQUIVALENT 1
RENISHAW MAYFIELD SARL
  SUBSTANTIALLY EQUIVALENT 2
RENSIHAW PLC
  SUBSTANTIALLY EQUIVALENT 1
SOTERIX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
VOYAGER THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1827 1827
2017 3501 3501
2018 4439 4439
2019 6062 6062
2020 3480 3480
2021 2454 2454

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 3279 3279
Human-Device Interface Problem 2652 2652
Mechanical Problem 2116 2116
Device Operates Differently Than Expected 1817 1817
Material Integrity Problem 1690 1690
Communication or Transmission Problem 1681 1681
Computer Software Problem 1567 1567
Application Program Freezes, Becomes Nonfunctional 1282 1282
Display or Visual Feedback Problem 1045 1045
Application Interface Becomes Non-Functional Or Program Exits Abnormally 967 967
Environmental Compatibility Problem 863 863
Adverse Event Without Identified Device or Use Problem 729 729
Output Problem 656 656
Device Stops Intermittently 597 597
Material Deformation 547 547
Break 475 475
Device Sensing Problem 461 461
Device Displays Incorrect Message 423 423
Use of Device Problem 382 382
No Display/Image 357 357
Disassembly 343 343
Electrical /Electronic Property Problem 322 322
Connection Problem 289 289
Unintended Movement 214 214
Fracture 188 188
Device Inoperable 155 155
Unintended Arm Motion 152 152
Mechanical Jam 147 147
Application Program Problem 117 117
Erratic or Intermittent Display 114 114
Improper or Incorrect Procedure or Method 103 103
Unintended Collision 99 99
Calibration Problem 87 87
Device Handling Problem 82 82
Bent 72 72
Insufficient Information 67 67
Image Display Error/Artifact 59 59
Computer Operating System Problem 57 57
Patient Data Problem 54 54
Loose or Intermittent Connection 47 47
Data Problem 43 43
Naturally Worn 40 40
Unintended Application Program Shut Down 39 39
Material Twisted/Bent 38 38
Positioning Problem 37 37
Failure to Obtain Sample 31 31
Failure to Calibrate 31 31
Mechanics Altered 29 29
Component Missing 28 28
Material Fragmentation 26 26
Poor Quality Image 26 26
Defective Component 25 25
Intermittent Communication Failure 25 25
Device-Device Incompatibility 24 24
Malposition of Device 24 24
Degraded 24 24
Excessive Heating 23 23
No Device Output 22 22
Device Operational Issue 22 22
Unstable 22 22
Failure to Power Up 21 21
Device Difficult to Setup or Prepare 21 21
Detachment of Device or Device Component 21 21
Incorrect Software Programming Calculations 18 18
Material Separation 17 17
Deformation Due to Compressive Stress 16 16
Image Orientation Incorrect 16 16
Device Emits Odor 15 15
Incorrect, Inadequate or Imprecise Resultor Readings 15 15
Appropriate Term/Code Not Available 15 15
Protective Measures Problem 13 13
Audible Prompt/Feedback Problem 13 13
Device Slipped 13 13
Loss of Data 12 12
Image Reversal 12 12
Problem with Software Installation 12 12
Material Frayed 11 11
Fitting Problem 11 11
Defective Device 10 10
Misconnection 10 10
Failure to Run on Battery 10 10
Incorrect Measurement 9 9
Intermittent Loss of Power 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Human Factors Issue 8 8
Difficult to Open or Close 8 8
Temperature Problem 8 8
Detachment Of Device Component 8 8
Device Issue 8 8
Sticking 8 8
Product Quality Problem 7 7
Difficult To Position 7 7
Loss of Power 6 6
Thermal Decomposition of Device 6 6
Physical Resistance/Sticking 6 6
Noise, Audible 6 6
Failure to Shut Off 6 6
Improper Device Output 6 6
Compatibility Problem 6 6
Device Contamination with Chemical or Other Material 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 8025 8025
No Known Impact Or Consequence To Patient 6322 6322
No Consequences Or Impact To Patient 3537 3537
No Clinical Signs, Symptoms or Conditions 3100 3100
Iatrogenic Source 407 407
No Code Available 320 320
Tissue Damage 240 240
Spinal Column Injury 140 140
Cerebrospinal Fluid Leakage 89 89
No Information 71 71
Injury 67 67
Neurological Deficit/Dysfunction 67 67
Hemorrhage/Bleeding 60 60
Unspecified Tissue Injury 51 51
Therapeutic Response, Decreased 44 44
Death 43 43
Hematoma 38 38
Unspecified Infection 38 38
Intracranial Hemorrhage 37 37
Brain Injury 37 37
Pain 28 28
Device Embedded In Tissue or Plaque 27 27
Foreign Body In Patient 27 27
Hemorrhage, Cerebral 26 26
Perforation 24 24
Blood Loss 23 23
Visual Impairment 22 22
Complaint, Ill-Defined 20 20
Insufficient Information 20 20
Nerve Damage 20 20
Muscle Weakness 16 16
Paralysis 16 16
Bone Fracture(s) 16 16
Post Operative Wound Infection 16 16
Paresis 15 15
Not Applicable 14 14
Seizures 11 11
Bacterial Infection 11 11
Radiation Exposure, Unintended 10 10
Dysphasia 10 10
Headache 9 9
Infarction, Cerebral 9 9
Edema 8 8
Skin Irritation 8 8
Impaired Healing 8 8
Meningitis 8 8
Numbness 8 8
Unspecified Nervous System Problem 8 8
Weakness 7 7
Burn(s) 7 7
Urinary Retention 6 6
Spinal Cord Injury 5 5
Convulsion/Seizure 5 5
Unintended Radiation Exposure 4 4
Hydrocephalus 4 4
Cognitive Changes 4 4
Urinary Tract Infection 4 4
Facial Nerve Paralysis 4 4
Swelling 4 4
Therapeutic Effects, Unexpected 4 4
Neuropathy 4 4
Inflammation 4 4
High Blood Pressure/ Hypertension 3 3
Myocardial Infarction 3 3
Nausea 3 3
Laceration(s) 3 3
Memory Loss/Impairment 3 3
Thrombosis 3 3
Renal Failure 3 3
Staphylococcus Aureus 3 3
Eye Injury 3 3
Hemorrhage, Subdural 3 3
Abscess 3 3
Pulmonary Embolism 3 3
Loss of Vision 3 3
Discomfort 3 3
Burn, Thermal 3 3
Paraplegia 3 3
Patient Problem/Medical Problem 3 3
Nervous System Injury 3 3
Full thickness (Third Degree) Burn 2 2
Encephalitis 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Confusion/ Disorientation 2 2
Coma 2 2
Depression 2 2
Vomiting 2 2
Dizziness 2 2
Wound Dehiscence 2 2
Bradycardia 2 2
Stroke/CVA 2 2
Dysphagia/ Odynophagia 2 2
Hemorrhage, Intraventricular 2 2
Hearing Loss 2 2
Hemorrhage, Extradural 2 2
Emotional Changes 2 2
Fever 2 2
Pleural Effusion 2 2
Skin Discoloration 2 2
Seizures, Focal Motor 1 1

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 Brainlab AG I Jan-19-2016
5 Elekta Inc II Apr-29-2020
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 Jul-27-2020
14 Medtronic Navigation, Inc. I May-18-2020
15 Medtronic Navigation, Inc. II Dec-06-2019
16 Medtronic Navigation, Inc. I Dec-29-2018
17 Medtronic Navigation, Inc. II Jun-26-2017
18 Medtronic Navigation, Inc. II Jan-11-2017
19 Medtronic Navigation, Inc. II Aug-02-2016
20 Medtronic Navigation, Inc. II Mar-24-2016
21 Medtronic Xomed, Inc. II Oct-21-2021
22 Orthosoft, Inc. dba Zimmer CAS II Jun-02-2017
23 Orthosoft, Inc. dba Zimmer CAS III May-12-2017
24 Orthosoft, Inc. dba Zimmer CAS II May-12-2017
25 Orthosoft, Inc. dba Zimmer CAS II May-08-2017
26 Stryker Instruments Div. of Stryker Corporation II Mar-27-2018
27 Synaptive Medical Inc I Nov-26-2018
28 Zimmer Biomet, Inc. II Feb-16-2018
29 Zimmer Biomet, Inc. II Nov-28-2017
30 Zimmer Biomet, Inc. II Nov-28-2017
31 Zimmer Biomet, Inc. II Nov-21-2017
32 Zimmer Biomet, Inc. II Nov-21-2017
33 Zimmer Biomet, Inc. II Nov-20-2017
34 Zimmer Biomet, Inc. II Nov-18-2017
35 Zimmer Biomet, Inc. II Nov-18-2017
36 Zimmer Biomet, Inc. II Nov-17-2017
37 Zimmer Biomet, Inc. II Nov-16-2017
38 Zimmer Biomet, Inc. II Nov-16-2017
39 Zimmer Biomet, Inc. II Nov-16-2017
40 Zimmer Biomet, Inc. II Nov-16-2017
41 Zimmer Biomet, Inc. II Sep-12-2017
42 Zimmer Biomet, Inc. II Aug-03-2017
43 Zimmer Biomet, Inc. II Mar-27-2017
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