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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
implant, hearing, active, middle ear, partially implanted
Product Code
MPV
Device Class
3
Premarket Approvals (PMA)
2016
2017
2018
2019
2020
2021
2022
2023
2024
2
0
0
0
1
0
1
0
0
MDR Year
MDR Reports
MDR Events
2016
65
65
2017
44
44
2018
53
53
2019
41
41
2020
54
54
2021
69
69
2022
57
57
2023
68
68
2024
49
49
Device Problems
MDRs with this Device Problem
Events in those MDRs
Output Problem
188
188
Device Operates Differently Than Expected
117
117
Migration
85
85
Adverse Event Without Identified Device or Use Problem
84
84
Device Appears to Trigger Rejection
63
63
No Device Output
62
62
Insufficient Information
47
47
Lack of Effect
5
5
Improper or Incorrect Procedure or Method
3
3
Malposition of Device
2
2
Positioning Problem
2
2
Device Handling Problem
2
2
Noise, Audible
2
2
Incomplete or Inadequate Connection
1
1
Circuit Failure
1
1
Intermittent Energy Output
1
1
Device Dislodged or Dislocated
1
1
Intermittent Continuity
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Failure of Implant
425
425
Skin Tears
30
30
Tissue Damage
24
24
Insufficient Information
22
22
No Clinical Signs, Symptoms or Conditions
21
21
Tissue Breakdown
17
17
Unspecified Infection
11
11
No Information
9
9
Bacterial Infection
8
8
Total Hearing Loss
5
5
Head Injury
5
5
Implant Pain
5
5
Wound Dehiscence
4
4
No Known Impact Or Consequence To Patient
4
4
Pain
4
4
Pressure Sores
3
3
Impaired Healing
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Skin Infection
2
2
Hearing Loss
2
2
Necrosis
2
2
Discomfort
2
2
Headache
2
2
Patient Problem/Medical Problem
1
1
Hearing Impairment
1
1
Idioventricular Rhythm
1
1
Inflammation
1
1
Irritation
1
1
Vertigo
1
1
Partial Hearing Loss
1
1
Undesired Nerve Stimulation
1
1
Perforation of Vessels
1
1
Therapeutic Effects, Unexpected
1
1
Meningitis
1
1
Granuloma
1
1
Deafness
1
1
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