• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 4
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 2262 2262

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 3237 3237
Human-Device Interface Problem 2642 2642
Mechanical Problem 2113 2113
Device Operates Differently Than Expected 1817 1817
Communication or Transmission Problem 1669 1669
Material Integrity Problem 1666 1666
Computer Software Problem 1565 1565
Application Program Freezes, Becomes Nonfunctional 1224 1224
Display or Visual Feedback Problem 1023 1023
Application Interface Becomes Non-Functional Or Program Exits Abnormally 967 967
Environmental Compatibility Problem 846 846
Adverse Event Without Identified Device or Use Problem 709 709
Output Problem 654 654
Device Stops Intermittently 597 597
Material Deformation 547 547
Break 475 475
Device Sensing Problem 441 441
Device Displays Incorrect Message 423 423
Use of Device Problem 374 374
No Display/Image 357 357
Disassembly 343 343
Electrical /Electronic Property Problem 321 321
Connection Problem 282 282
Unintended Movement 214 214
Fracture 188 188
Device Inoperable 155 155
Unintended Arm Motion 152 152
Mechanical Jam 146 146
Application Program Problem 117 117
Erratic or Intermittent Display 114 114
Improper or Incorrect Procedure or Method 102 102
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 54 54
Patient Data Problem 53 53
Loose or Intermittent Connection 46 46
Data Problem 42 42
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
Component Missing 28 28
Mechanics Altered 28 28
Poor Quality Image 26 26
Material Fragmentation 26 26
Defective Component 25 25
Intermittent Communication Failure 25 25
Malposition of Device 24 24
Device-Device Incompatibility 24 24
Degraded 24 24
Excessive Heating 23 23
Unstable 22 22
No Device Output 22 22
Device Operational Issue 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
Appropriate Term/Code Not Available 15 15
Incorrect, Inadequate or Imprecise Resultor Readings 14 14
Device Slipped 13 13
Protective Measures Problem 13 13
Audible Prompt/Feedback Problem 13 13
Loss of Data 12 12
Problem with Software Installation 12 12
Image Reversal 12 12
Fitting Problem 11 11
Material Frayed 11 11
Failure to Run on Battery 10 10
Misconnection 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Incorrect Measurement 9 9
Defective Device 9 9
Intermittent Loss of Power 9 9
Human Factors Issue 8 8
Temperature Problem 8 8
Difficult to Open or Close 8 8
Device Issue 8 8
Sticking 8 8
Detachment Of Device Component 8 8
Difficult To Position 7 7
Loss of Power 6 6
Noise, Audible 6 6
Thermal Decomposition of Device 6 6
Product Quality Problem 6 6
Improper Device Output 6 6
Compatibility Problem 6 6
Physical Resistance/Sticking 6 6
Device Contamination with Chemical or Other Material 5 5
Device Markings/Labelling Problem 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 2929 2929
Iatrogenic Source 407 407
No Code Available 320 320
Tissue Damage 240 240
Spinal Column Injury 140 140
Cerebrospinal Fluid Leakage 86 86
No Information 71 71
Injury 67 67
Neurological Deficit/Dysfunction 67 67
Hemorrhage/Bleeding 55 55
Unspecified Tissue Injury 45 45
Therapeutic Response, Decreased 44 44
Death 43 43
Brain Injury 37 37
Hematoma 36 36
Unspecified Infection 34 34
Intracranial Hemorrhage 33 33
Pain 27 27
Foreign Body In Patient 27 27
Device Embedded In Tissue or Plaque 26 26
Hemorrhage, Cerebral 26 26
Perforation 24 24
Blood Loss 23 23
Visual Impairment 21 21
Nerve Damage 20 20
Complaint, Ill-Defined 20 20
Insufficient Information 17 17
Post Operative Wound Infection 16 16
Paralysis 15 15
Bone Fracture(s) 15 15
Paresis 15 15
Muscle Weakness 15 15
Not Applicable 14 14
Seizures 11 11
Radiation Exposure, Unintended 10 10
Dysphasia 9 9
Headache 9 9
Infarction, Cerebral 9 9
Bacterial Infection 9 9
Edema 8 8
Impaired Healing 8 8
Meningitis 8 8
Numbness 8 8
Skin Irritation 8 8
Burn(s) 7 7
Weakness 7 7
Unspecified Nervous System Problem 6 6
Urinary Retention 6 6
Spinal Cord Injury 5 5
Cognitive Changes 4 4
Convulsion/Seizure 4 4
Unintended Radiation Exposure 4 4
Neuropathy 4 4
Swelling 4 4
Therapeutic Effects, Unexpected 4 4
Facial Nerve Paralysis 4 4
Hemorrhage, Subdural 3 3
Urinary Tract Infection 3 3
Loss of Vision 3 3
Eye Injury 3 3
Laceration(s) 3 3
Myocardial Infarction 3 3
Nausea 3 3
Hydrocephalus 3 3
Patient Problem/Medical Problem 3 3
Nervous System Injury 3 3
Burn, Thermal 3 3
Discomfort 3 3
Thrombosis 3 3
Staphylococcus Aureus 3 3
Inflammation 3 3
Memory Loss/Impairment 3 3
Pulmonary Embolism 3 3
Abscess 3 3
Dysphagia/ Odynophagia 2 2
Wound Dehiscence 2 2
Hemorrhage, Extradural 2 2
Hemorrhage, Intraventricular 2 2
High Blood Pressure/ Hypertension 2 2
Hearing Loss 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Coma 2 2
Skin Discoloration 2 2
Dizziness 2 2
Encephalitis 2 2
Paraplegia 2 2
Depression 2 2
Confusion/ Disorientation 2 2
Full thickness (Third Degree) Burn 2 2
Vomiting 2 2
Bradycardia 2 2
Stroke/CVA 2 2
Ossification 1 1
Bruise/Contusion 1 1
Embolus 1 1
Coagulation Disorder 1 1
Contusion 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 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. II Jul-27-2020
13 Medtronic Navigation, Inc. I May-18-2020
14 Medtronic Navigation, Inc. II Dec-06-2019
15 Medtronic Navigation, Inc. I Dec-29-2018
16 Medtronic Navigation, Inc. II Jun-26-2017
17 Medtronic Navigation, Inc. II Jan-11-2017
18 Medtronic Navigation, Inc. II Aug-02-2016
19 Medtronic Navigation, Inc. II Mar-24-2016
20 Orthosoft, Inc. dba Zimmer CAS II Jun-02-2017
21 Orthosoft, Inc. dba Zimmer CAS III May-12-2017
22 Orthosoft, Inc. dba Zimmer CAS II May-12-2017
23 Orthosoft, Inc. dba Zimmer CAS II May-08-2017
24 Stryker Instruments Div. of Stryker Corporation II Mar-27-2018
25 Synaptive Medical Inc I Nov-26-2018
26 Zimmer Biomet, Inc. II Feb-16-2018
27 Zimmer Biomet, Inc. II Nov-28-2017
28 Zimmer Biomet, Inc. II Nov-28-2017
29 Zimmer Biomet, Inc. II Nov-21-2017
30 Zimmer Biomet, Inc. II Nov-21-2017
31 Zimmer Biomet, Inc. II Nov-20-2017
32 Zimmer Biomet, Inc. II Nov-18-2017
33 Zimmer Biomet, Inc. II Nov-18-2017
34 Zimmer Biomet, Inc. II Nov-17-2017
35 Zimmer Biomet, Inc. II Nov-16-2017
36 Zimmer Biomet, Inc. II Nov-16-2017
37 Zimmer Biomet, Inc. II Nov-16-2017
38 Zimmer Biomet, Inc. II Nov-16-2017
39 Zimmer Biomet, Inc. II Sep-12-2017
40 Zimmer Biomet, Inc. II Aug-03-2017
41 Zimmer Biomet, Inc. II Mar-27-2017
-
-