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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
ACUMED LLC
  SUBSTANTIALLY EQUIVALENT 1
ARC SURGICAL LLC.
  SUBSTANTIALLY EQUIVALENT 1
BLUE ORTHO
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 2
CLARONAV INC.
  SUBSTANTIALLY EQUIVALENT 1
DEERFIELD IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA INSTRUMENT AB
  SUBSTANTIALLY EQUIVALENT 3
FIAGON GMBH
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
IZI MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2
MEDTECH S.A.
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 7
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MRI INTERVENTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
RENISHAW MAYFIELD SARL
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER LEIBINGER GMBH & CO. KG - NAVIGATION
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIVE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 4

MDR Year MDR Reports MDR Events
2015 1767 1767
2016 1827 1827
2017 3501 3501
2018 4439 4439
2019 6061 6061
2020 2317 2317

Device Problems MDRs with this Device Problem Events in those MDRs
Imprecision 3130 3130
Human-Device Interface Problem 2478 2478
Mechanical Problem 2108 2108
Device Operates Differently Than Expected 2060 2060
Computer Software Problem 1475 1475
Communication or Transmission Problem 1364 1364
Material Integrity Problem 1354 1354
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1226 1226
Display or Visual Feedback Problem 787 787
Device Stops Intermittently 743 743
Material Deformation 695 695
Break 648 648
Output Problem 646 646
Adverse Event Without Identified Device or Use Problem 588 588
Environmental Compatibility Problem 586 586
Device Displays Incorrect Message 488 488
Monitor 440 440
Disassembly 412 412
No Display/Image 408 408
Electrical /Electronic Property Problem 321 321
Unintended Movement 308 308
Use of Device Problem 290 290
Camera 276 276
Clamp 273 273
Application Program Freezes, Becomes Nonfunctional 259 259
Unintended Arm Motion 227 227
Screw 210 210
CPU (Central Processing Unit Of Computer System) 184 184
Device Inoperable 167 167
Fracture 160 160
Emitter 154 154
Erratic or Intermittent Display 138 138
Mechanical Jam 123 123
Cable, Electrical 121 121
Application Program Problem 117 117
Device Sensing Problem 103 103
Improper or Incorrect Procedure or Method 98 98
Calibration Problem 92 92
Bent 88 88
Unintended Collision 88 88
Device Handling Problem 82 82
Connection Problem 80 80
Probe 78 78
Computer Hardware 70 70
Device Issue 68 68
Insufficient Information 61 61
Driver 60 60
Positioning Problem 59 59
Loose or Intermittent Connection 52 52
Guide 50 50
Image Display Error/Artifact 47 47
Naturally Worn 47 47
Tip 40 40
Power Cord 38 38
Unstable 38 38
Caster 37 37
Material Twisted/Bent 37 37
Battery 34 34
Frame 33 33
Failure to Calibrate 33 33
Failure to Obtain Sample 32 32
Data Problem 30 30
Component Missing 28 28
No Device Output 27 27
Needle 27 27
Poor Quality Image 27 27
Computer Operating System Problem 26 26
Defective Component 25 25
Material Fragmentation 24 24
Failure to Power Up 23 23
Device-Device Incompatibility 23 23
Device Operational Issue 22 22
Detachment of Device or Device Component 21 21
Unintended Application Program Shut Down 21 21
Device Difficult to Setup or Prepare 21 21
Device Slipped 20 20
Image Reversal 20 20
Display 19 19
Degraded 19 19
Malposition of Device 19 19
Image Orientation Incorrect 19 19
Incorrect Software Programming Calculations 18 18
Device Emits Odor 18 18
Appropriate Term/Code Not Available 17 17
LED (Light Emitting Diode) 17 17
Intermittent Communication Failure 16 16
Mechanics Altered 16 16
Deformation Due to Compressive Stress 15 15
Material Separation 14 14
Excessive Heating 14 14
Detachment Of Device Component 13 13
Thread 13 13
Locking Mechanism 12 12
Material Frayed 12 12
Sticking 12 12
Protective Measures Problem 11 11
Defective Device 10 10
Difficult to Open or Close 10 10
Improper Device Output 10 10
Screw Head 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 8198 8198
No Known Impact Or Consequence To Patient 6334 6334
No Consequences Or Impact To Patient 4215 4215
Iatrogenic Source 513 513
No Code Available 303 303
Tissue Damage 232 232
Spinal Column Injury 212 212
No Information 81 81
Injury 70 70
Cerebrospinal Fluid Leakage 69 69
Neurological Deficit/Dysfunction 68 68
Therapeutic Response, Decreased 52 52
Brain Injury 48 48
Death 44 44
Hemorrhage/Bleeding 44 44
Hematoma 30 30
Intracranial Hemorrhage 29 29
Unspecified Infection 28 28
Foreign Body In Patient 28 28
Device Embedded In Tissue or Plaque 27 27
Perforation 27 27
Hemorrhage, Cerebral 26 26
Blood Loss 26 26
Pain 24 24
Visual Impairment 19 19
Complaint, Ill-Defined 19 19
Nerve Damage 17 17
Paresis 17 17
Post Operative Wound Infection 15 15
Not Applicable 15 15
Paralysis 14 14
Bone Fracture(s) 14 14
Seizures 11 11
Radiation Exposure, Unintended 11 11
Therapeutic Effects, Unexpected 11 11
Muscle Weakness 10 10
Numbness 9 9
Weakness 9 9
Infarction, Cerebral 9 9
Bacterial Infection 7 7
Meningitis 7 7
Skin Irritation 7 7
Burn(s) 7 7
Impaired Healing 6 6
Dysphasia 6 6
Edema 6 6
Head Injury 5 5
Urinary Retention 5 5
Spinal Cord Injury 5 5
Cognitive Changes 4 4
Swelling 4 4
Headache 4 4
Nervous System Injury 4 4
Hydrocephalus 4 4
Patient Problem/Medical Problem 3 3
Discomfort 3 3
Burn, Thermal 3 3
Facial Nerve Paralysis 3 3
Hemorrhage, Subdural 3 3
Loss of Vision 3 3
Laceration(s) 3 3
Myocardial Infarction 3 3
Staphylococcus Aureus 3 3
Skin Discoloration 3 3
Neuropathy 3 3
Inflammation 3 3
Memory Loss/Impairment 3 3
Pulmonary Embolism 3 3
Thrombosis 3 3
Coma 2 2
Abscess 2 2
Wound Dehiscence 2 2
Dysphagia/ Odynophagia 2 2
Hemorrhage, Extradural 2 2
Exsanguination 2 2
Hemorrhage, Intraventricular 2 2
High Blood Pressure/ Hypertension 2 2
Hearing Loss 2 2
Dizziness 2 2
Eye Injury 2 2
Confusion/ Disorientation 2 2
Encephalitis 2 2
Paraplegia 2 2
Tissue Breakdown 2 2
Full thickness (Third Degree) Burn 1 1
Disc Impingement 1 1
Missing Value Reason 1 1
Needle Stick/Puncture 1 1
Depression 1 1
Peroneal Nerve Palsy 1 1
Dyskinesia 1 1
Ossification 1 1
Embolus 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Coagulation Disorder 1 1
Contusion 1 1
Hemothorax 1 1
Hypoxia 1 1
Hemorrhage, Subarachnoid 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Brainlab AG I Apr-15-2019
2 Brainlab AG II Jan-05-2018
3 Brainlab AG I Jan-19-2016
4 Brainlab AG II Nov-17-2015
5 Brainlab AG II Nov-11-2015
6 Elekta Inc II Apr-29-2020
7 Elekta Instrument AB II Jul-10-2020
8 FHC, Inc. II Jul-05-2018
9 Integra LifeSciences Corp. II Oct-06-2015
10 MEDTECH SAS II Feb-11-2020
11 MEDTECH SAS I Nov-01-2019
12 MEDTECH SAS II Jun-07-2018
13 Mazor Robotics Ltd II Dec-14-2018
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 Navigation, Inc. II Aug-02-2016
21 Medtronic Navigation, Inc. II Mar-24-2016
22 Medtronic Navigation, Inc. II Sep-30-2015
23 Medtronic Navigation, Inc. II Aug-03-2015
24 Medtronic Navigation, Inc. II Jun-26-2015
25 Medtronic Navigation, Inc. II Jun-12-2015
26 Northern Digital Inc. II Jul-16-2015
27 Northern Digital Inc. II Jul-16-2015
28 Orthosoft, Inc. dba Zimmer CAS II Jun-02-2017
29 Orthosoft, Inc. dba Zimmer CAS III May-12-2017
30 Orthosoft, Inc. dba Zimmer CAS II May-12-2017
31 Orthosoft, Inc. dba Zimmer CAS II May-08-2017
32 Stryker Instruments Div. of Stryker Corporation II Mar-27-2018
33 Stryker Instruments Div. of Stryker Corporation II Jun-16-2015
34 Synaptive Medical Inc I Nov-26-2018
35 Synaptive Medical, Inc. II Dec-23-2015
36 Zimmer Biomet, Inc. II Feb-16-2018
37 Zimmer Biomet, Inc. II Nov-28-2017
38 Zimmer Biomet, Inc. II Nov-28-2017
39 Zimmer Biomet, Inc. II Nov-21-2017
40 Zimmer Biomet, Inc. II Nov-21-2017
41 Zimmer Biomet, Inc. II Nov-20-2017
42 Zimmer Biomet, Inc. II Nov-18-2017
43 Zimmer Biomet, Inc. II Nov-18-2017
44 Zimmer Biomet, Inc. II Nov-17-2017
45 Zimmer Biomet, Inc. II Nov-16-2017
46 Zimmer Biomet, Inc. II Nov-16-2017
47 Zimmer Biomet, Inc. II Nov-16-2017
48 Zimmer Biomet, Inc. II Nov-16-2017
49 Zimmer Biomet, Inc. II Sep-12-2017
50 Zimmer Biomet, Inc. II Aug-03-2017
51 Zimmer Biomet, Inc. II Mar-27-2017
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