|
Device |
neurological stereotaxic instrument |
Product Code | HAW |
Regulation Number |
882.4560
|
Device Class |
2
|
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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