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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 3
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 6
CLARONAV INC.
  SUBSTANTIALLY EQUIVALENT 1
CLEARPOINT NEURO, INC.
  SUBSTANTIALLY EQUIVALENT 2
EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA INSTRUMENT AB
  SUBSTANTIALLY EQUIVALENT 2
FIAGON GMBH
  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 4
MRI INTERVENTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
MRI INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 1
THERATAXIS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VOYAGER THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 3501 3501
2018 4439 4439
2019 6062 6062
2020 3480 3480
2021 2830 2830
2022 609 609

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 3060 3060
Human-Device Interface Problem 2691 2691
Mechanical Problem 2107 2107
Material Integrity Problem 1836 1836
Device Operates Differently Than Expected 1651 1651
Computer Software Problem 1516 1516
Application Program Freezes, Becomes Nonfunctional 1514 1514
Communication or Transmission Problem 1478 1478
Display or Visual Feedback Problem 1061 1061
Environmental Compatibility Problem 959 959
Application Interface Becomes Non-Functional Or Program Exits Abnormally 754 754
Adverse Event Without Identified Device or Use Problem 740 740
Output Problem 671 671
Device Sensing Problem 590 590
Use of Device Problem 390 390
Device Stops Intermittently 376 376
Material Deformation 364 364
Connection Problem 359 359
Break 336 336
Device Displays Incorrect Message 328 328
Electrical /Electronic Property Problem 287 287
No Display/Image 268 268
Disassembly 259 259
Fracture 177 177
Mechanical Jam 144 144
Application Program Problem 115 115
Device Inoperable 113 113
Unintended Collision 102 102
Erratic or Intermittent Display 99 99
Improper or Incorrect Procedure or Method 99 99
Unintended Movement 96 96
Calibration Problem 80 80
Unintended Arm Motion 67 67
Device Handling Problem 67 67
Insufficient Information 66 66
Computer Operating System Problem 65 65
Image Display Error/Artifact 59 59
Patient Data Problem 54 54
Data Problem 44 44
Loose or Intermittent Connection 42 42
Unintended Application Program Shut Down 40 40
Material Twisted/Bent 39 39
Positioning Problem 35 35
Bent 34 34
Mechanics Altered 33 33
Malposition of Device 31 31
Failure to Obtain Sample 31 31
Failure to Calibrate 29 29
Incorrect, Inadequate or Imprecise Resultor Readings 26 26
Excessive Heating 26 26
Intermittent Communication Failure 25 25
Component Missing 25 25
Defective Component 24 24
Device-Device Incompatibility 24 24
Degraded 24 24
Material Fragmentation 23 23
Device Operational Issue 22 22
Naturally Worn 22 22
Detachment of Device or Device Component 21 21
Poor Quality Image 21 21
Failure to Power Up 21 21
Device Difficult to Setup or Prepare 20 20
Incorrect Software Programming Calculations 18 18
Material Separation 17 17
Deformation Due to Compressive Stress 17 17
Image Orientation Incorrect 16 16
Appropriate Term/Code Not Available 16 16
Audible Prompt/Feedback Problem 15 15
Protective Measures Problem 15 15
No Device Output 15 15
Device Emits Odor 12 12
Incorrect Measurement 12 12
Problem with Software Installation 12 12
Loss of Data 11 11
Misconnection 10 10
Failure to Run on Battery 10 10
Delivered as Unsterile Product 9 9
Material Frayed 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Intermittent Loss of Power 9 9
Temperature Problem 8 8
Defective Device 8 8
Device Issue 8 8
Fitting Problem 7 7
Unstable 7 7
Device Slipped 7 7
Product Quality Problem 7 7
Difficult to Open or Close 7 7
Compatibility Problem 7 7
Failure to Shut Off 6 6
No Apparent Adverse Event 6 6
Physical Resistance/Sticking 6 6
Noise, Audible 6 6
Program or Algorithm Execution Failure 6 6
Loss of Power 6 6
Misassembled 5 5
Positioning Failure 5 5
Device Markings/Labelling Problem 5 5
Biocompatibility 5 5
Inaccurate Delivery 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 7475 7475
No Known Impact Or Consequence To Patient 6160 6160
No Clinical Signs, Symptoms or Conditions 4012 4012
No Consequences Or Impact To Patient 2578 2578
No Code Available 313 313
Iatrogenic Source 285 285
Tissue Damage 231 231
Cerebrospinal Fluid Leakage 86 86
Hemorrhage/Bleeding 69 69
Unspecified Tissue Injury 68 68
Spinal Column Injury 66 66
Injury 61 61
Neurological Deficit/Dysfunction 59 59
No Information 50 50
Unspecified Infection 43 43
Intracranial Hemorrhage 42 42
Hematoma 41 41
Insufficient Information 37 37
Therapeutic Response, Decreased 36 36
Death 35 35
Hemorrhage, Cerebral 26 26
Pain 25 25
Brain Injury 25 25
Device Embedded In Tissue or Plaque 25 25
Foreign Body In Patient 23 23
Muscle Weakness 23 23
Visual Impairment 22 22
Complaint, Ill-Defined 20 20
Nerve Damage 19 19
Post Operative Wound Infection 19 19
Perforation 19 19
Paralysis 17 17
Bone Fracture(s) 17 17
Blood Loss 17 17
Unspecified Nervous System Problem 17 17
Bacterial Infection 15 15
Paresis 15 15
Not Applicable 14 14
Dysphasia 13 13
Numbness 11 11
Radiation Exposure, Unintended 10 10
Seizures 10 10
Headache 9 9
Infarction, Cerebral 9 9
Convulsion/Seizure 9 9
Impaired Healing 8 8
Meningitis 8 8
Weakness 7 7
Spinal Cord Injury 7 7
Burn(s) 7 7
Edema 6 6
Cognitive Changes 6 6
Hydrocephalus 6 6
Urinary Retention 6 6
Skin Irritation 5 5
Neuropathy 5 5
Memory Loss/Impairment 5 5
Inflammation 4 4
High Blood Pressure/ Hypertension 4 4
Facial Nerve Paralysis 4 4
Urinary Tract Infection 4 4
Swelling 4 4
Thrombosis/Thrombus 4 4
Unintended Radiation Exposure 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Loss of Vision 3 3
Thrombosis 3 3
Discomfort 3 3
Patient Problem/Medical Problem 3 3
Tissue Breakdown 3 3
Burn, Thermal 3 3
Paraplegia 3 3
Eye Injury 3 3
Abscess 3 3
Pulmonary Embolism 3 3
Hemorrhage, Subdural 3 3
Laceration(s) 3 3
Myocardial Infarction 3 3
Nausea 3 3
Renal Failure 3 3
Staphylococcus Aureus 3 3
Pleural Effusion 2 2
Wound Dehiscence 2 2
Stroke/CVA 2 2
Bradycardia 2 2
Dysphagia/ Odynophagia 2 2
Hearing Loss 2 2
Fever 2 2
Hemorrhage, Extradural 2 2
Hemorrhage, Intraventricular 2 2
Coma 2 2
Ambulation Difficulties 2 2
Confusion/ Disorientation 2 2
Encephalitis 2 2
Nervous System Injury 2 2
Full thickness (Third Degree) Burn 2 2
Speech Disorder 2 2
Depression 2 2
Vomiting 2 2
Dizziness 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 Navigation, Inc. II Jun-26-2017
19 Medtronic Navigation, Inc. II Jan-11-2017
20 Medtronic Xomed, Inc. II Oct-21-2021
21 Orthosoft, Inc. dba Zimmer CAS II Jun-02-2017
22 Orthosoft, Inc. dba Zimmer CAS III May-12-2017
23 Orthosoft, Inc. dba Zimmer CAS II May-12-2017
24 Orthosoft, Inc. dba Zimmer CAS II May-08-2017
25 Stryker Instruments Div. of Stryker Corporation II Mar-27-2018
26 Synaptive Medical Inc I Nov-26-2018
27 Zimmer Biomet, Inc. II Feb-16-2018
28 Zimmer Biomet, Inc. II Nov-28-2017
29 Zimmer Biomet, Inc. II Nov-28-2017
30 Zimmer Biomet, Inc. II Nov-21-2017
31 Zimmer Biomet, Inc. II Nov-21-2017
32 Zimmer Biomet, Inc. II Nov-20-2017
33 Zimmer Biomet, Inc. II Nov-18-2017
34 Zimmer Biomet, Inc. II Nov-18-2017
35 Zimmer Biomet, Inc. II Nov-17-2017
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 Nov-16-2017
40 Zimmer Biomet, Inc. II Sep-12-2017
41 Zimmer Biomet, Inc. II Aug-03-2017
42 Zimmer Biomet, Inc. II Mar-27-2017
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