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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
motor, drill, pneumatic
Product Code
HBB
Regulation Number
882.4370
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
284
722
2020
263
372
2021
260
419
2022
172
332
2023
180
306
2024
101
200
Device Problems
MDRs with this Device Problem
Events in those MDRs
Output below Specifications
314
314
Overheating of Device
203
611
Material Puncture/Hole
157
157
Detachment of Device or Device Component
124
149
Fluid/Blood Leak
92
502
No Apparent Adverse Event
78
78
Break
55
53
Unintended System Motion
46
46
Noise, Audible
43
43
Leak/Splash
42
272
Material Twisted/Bent
36
36
Vibration
35
35
Complete Loss of Power
32
32
Excessive Heating
32
32
Physical Resistance/Sticking
28
29
Burst Container or Vessel
27
41
Device Remains Activated
25
25
Fracture
21
21
Electrical /Electronic Property Problem
19
19
Unintended Power Up
15
22
Naturally Worn
14
14
Appropriate Term/Code Not Available
14
14
Mechanical Jam
11
11
Difficult to Insert
11
11
Material Rupture
11
11
Adverse Event Without Identified Device or Use Problem
10
10
Difficult to Remove
9
9
Premature Separation
8
8
Misconnection
7
7
Material Fragmentation
7
7
Mechanical Problem
5
5
Unexpected Shutdown
5
5
Insufficient Information
5
5
Intermittent Loss of Power
4
4
Gas/Air Leak
4
4
Energy Output Problem
4
4
Fail-Safe Problem
4
9
Failure to Auto Stop
3
3
Device-Device Incompatibility
3
3
Loss of Power
3
3
Degraded
3
3
Fail-Safe Did Not Operate
3
3
Smoking
2
2
Device Slipped
1
1
Device Damaged by Another Device
1
1
Defective Component
1
1
Component Missing
1
1
Dull, Blunt
1
1
Structural Problem
1
1
Loose or Intermittent Connection
1
1
Entrapment of Device
1
1
Material Discolored
1
1
No Display/Image
1
1
Device Reprocessing Problem
1
1
Intermittent Energy Output
1
1
Separation Problem
1
1
Difficult or Delayed Separation
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Positioning Problem
1
1
Unintended Movement
1
1
Device Fell
1
1
Explosion
1
1
Ejection Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
728
1412
No Consequences Or Impact To Patient
315
541
No Patient Involvement
104
511
No Known Impact Or Consequence To Patient
75
213
Insufficient Information
16
87
Chemical Exposure
13
13
Perforation
12
12
Injury
9
9
Burn(s)
8
8
Unintended Radiation Exposure
8
8
Device Embedded In Tissue or Plaque
7
7
Unspecified Tissue Injury
6
6
Cerebrospinal Fluid Leakage
6
6
Hearing Impairment
6
6
Hemorrhage/Bleeding
5
5
Unspecified Infection
5
5
Tissue Damage
5
5
Foreign Body In Patient
4
4
Nerve Damage
4
4
Spinal Column Injury
4
4
Tinnitus
3
3
Death
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
No Information
2
55
Spinal Cord Injury
2
2
Pain
2
2
Acoustic Trauma
1
2
Oversedation
1
1
Laceration(s)
1
1
Muscle Weakness
1
1
Fatigue
1
1
Headache
1
1
Contusion
1
1
Intracranial Hemorrhage
1
1
Failure of Implant
1
1
Hematoma
1
1
Reaction
1
1
Numbness
1
1
No Code Available
1
1
Partial thickness (Second Degree) Burn
1
3
Radiation Exposure, Unintended
1
1
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