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TPLC
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Device
motor, drill, pneumatic
Regulation Description
Pneumatic cranial drill motor.
Product Code
HBB
Regulation Number
882.4370
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
263
372
2021
260
419
2022
172
332
2023
180
306
2024
759
977
2025
735
811
Device Problems
MDRs with this Device Problem
Events in those MDRs
Overheating of Device
831
1297
Detachment of Device or Device Component
604
639
No Apparent Adverse Event
194
194
Output below Specifications
179
179
Material Puncture/Hole
141
141
Difficult to Insert
104
104
Noise, Audible
89
89
Fluid/Blood Leak
88
414
Naturally Worn
83
83
Vibration
70
70
Break
66
65
Fracture
54
54
Loss of Power
50
50
Difficult to Remove
49
49
Physical Resistance/Sticking
46
47
Unintended System Motion
45
45
Material Twisted/Bent
43
43
Excessive Heating
40
40
Device Remains Activated
35
35
Complete Loss of Power
33
33
Corroded
31
31
Electrical /Electronic Property Problem
29
29
Burst Container or Vessel
25
36
Appropriate Term/Code Not Available
19
19
Leak/Splash
16
16
Fail-Safe Did Not Operate
16
16
Mechanical Jam
13
13
Unintended Power Up
12
20
Premature Separation
11
11
Smoking
10
10
Material Deformation
10
10
Adverse Event Without Identified Device or Use Problem
10
10
Misconnection
10
10
Device Displays Incorrect Message
9
9
Material Rupture
9
9
Fail-Safe Problem
7
10
Material Fragmentation
6
6
Insufficient Information
5
5
Gas/Air Leak
4
4
Energy Output Problem
4
4
Device-Device Incompatibility
4
4
Degraded
3
3
Material Integrity Problem
3
3
Failure to Auto Stop
3
3
Mechanical Problem
3
3
Dull, Blunt
3
3
Device Contaminated During Manufacture or Shipping
3
3
Explosion
2
2
Device Reprocessing Problem
2
2
Defective Component
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
2075
2899
No Consequences Or Impact To Patient
164
186
Insufficient Information
71
207
No Patient Involvement
35
120
Burn(s)
14
14
Chemical Exposure
13
13
Unintended Radiation Exposure
12
12
No Known Impact Or Consequence To Patient
11
11
Device Embedded In Tissue or Plaque
8
8
Perforation
7
7
Injury
6
6
Unspecified Tissue Injury
6
6
Cerebrospinal Fluid Leakage
6
6
Hearing Impairment
5
5
Unspecified Infection
5
5
Tissue Damage
5
5
Hemorrhage/Bleeding
5
5
Spinal Column Injury
4
4
Nerve Damage
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Tinnitus
3
3
Pain
2
2
Spinal Cord Injury
2
2
Muscle Weakness
1
1
Foreign Body In Patient
1
1
Oversedation
1
1
Intracranial Hemorrhage
1
1
Numbness
1
1
Laceration(s)
1
1
Awareness during Anaesthesia
1
1
Reaction
1
1
Partial thickness (Second Degree) Burn
1
3
Headache
1
1
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