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TPLC
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show TPLC since
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Device
prosthesis, nose, internal
Product Code
FZE
Regulation Number
878.3680
Device Class
2
Premarket Reviews
Manufacturer
Decision
HANSON MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
NOBEL BIOCARE AB
SUBSTANTIALLY EQUIVALENT
1
SOUTHERN IMPLANTS (PTY) LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
7
7
2017
13
13
2018
12
12
2019
24
24
2020
23
23
2021
32
32
2022
30
30
2023
14
14
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Appropriate Term/Code Not Available
66
66
Patient Device Interaction Problem
45
45
Loss of Osseointegration
31
31
Adverse Event Without Identified Device or Use Problem
17
17
Osseointegration Problem
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
33
33
Impaired Healing
33
33
No Code Available
17
17
Skin Infection
14
14
Patient Problem/Medical Problem
14
14
Host-Tissue Reaction
11
11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
10
10
No Clinical Signs, Symptoms or Conditions
9
9
Inadequate Osseointegration
8
8
Skin Inflammation/ Irritation
6
6
Pain
5
5
No Consequences Or Impact To Patient
4
4
Bacterial Infection
3
3
Hearing Impairment
3
3
Hematoma
2
2
Swelling/ Edema
2
2
Head Injury
2
2
Scar Tissue
2
2
Skin Irritation
1
1
Swelling
1
1
Abscess
1
1
Tissue Breakdown
1
1
No Information
1
1
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