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TPLC
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show TPLC since
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Device
osseoanchored prostheses for the rehabilitation of transfemoral amputees
Definition
The device is a percutaneous prosthetic device for the direct skeletal attachment of a prosthetic limb.
Product Code
PJY
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
0
0
0
0
0
0
0
0
0
0
0
1
2
0
2
1
MDR Year
MDR Reports
MDR Events
2017
2
2
2018
16
16
2019
9
9
2020
14
14
2021
25
25
2022
26
26
2023
60
60
2024
44
44
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
68
68
Adverse Event Without Identified Device or Use Problem
53
53
Mechanical Problem
22
22
Insufficient Information
21
21
Fracture
11
11
Device Dislodged or Dislocated
8
8
Microbial Contamination of Device
8
8
Device Fell
6
6
Off-Label Use
6
6
Osseointegration Problem
6
6
Loss of Osseointegration
5
5
Failure to Osseointegrate
3
3
Device Slipped
2
2
Unintended Movement
2
2
Appropriate Term/Code Not Available
2
2
Break
2
2
Loose or Intermittent Connection
2
2
Activation, Positioning or Separation Problem
1
1
Unclear Information
1
1
Material Integrity Problem
1
1
No Apparent Adverse Event
1
1
Device Operates Differently Than Expected
1
1
Patient Device Interaction Problem
1
1
Noise, Audible
1
1
Detachment Of Device Component
1
1
Component Falling
1
1
Loss of or Failure to Bond
1
1
Migration or Expulsion of Device
1
1
Physical Resistance/Sticking
1
1
Improper or Incorrect Procedure or Method
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
55
55
Fall
31
31
Implant Pain
26
26
Insufficient Information
20
20
Unspecified Infection
14
14
Failure of Implant
13
13
Fluid Discharge
13
13
No Code Available
12
12
Pain
11
11
Osteomyelitis
9
9
No Known Impact Or Consequence To Patient
7
7
Bacterial Infection
4
4
Inadequate Osseointegration
3
3
No Consequences Or Impact To Patient
3
3
Bruise/Contusion
3
3
Purulent Discharge
2
2
Missing Value Reason
2
2
Subclinical Infection
1
1
Death
1
1
Hip Fracture
1
1
Necrosis
1
1
Bone Fracture(s)
1
1
Localized Skin Lesion
1
1
Injury
1
1
Thrombosis/Thrombus
1
1
Osteolysis
1
1
Limb Fracture
1
1
Abscess
1
1
Headache
1
1
External Prosthetic Device Pain
1
1
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