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TPLC
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show TPLC since
2009
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Device
joint, knee, external limb component
Product Code
ISY
Regulation Number
890.3420
Device Class
1
Premarket Reviews
Manufacturer
Decision
RIZZOLI ORTOPEDICA S.P.A.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2015
20
20
2016
49
49
2017
87
87
2018
34
34
2019
22
22
2020
80
80
2021
35
35
2022
23
23
2023
24
24
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
164
164
Device Operates Differently Than Expected
65
65
Device Handling Problem
40
40
Unintended System Motion
38
38
Adverse Event Without Identified Device or Use Problem
22
22
Insufficient Information
14
14
Physical Resistance/Sticking
11
11
Loose or Intermittent Connection
8
8
Device Slipped
7
7
Break
5
5
Component Missing
4
4
Failure To Service
2
2
Fracture
2
2
Crack
2
2
Improper or Incorrect Procedure or Method
2
2
Device Fell
1
1
Misassembled During Installation
1
1
Appropriate Term/Code Not Available
1
1
Patient Device Interaction Problem
1
1
Stretched
1
1
Use of Device Problem
1
1
Positioning Problem
1
1
Human Factors Issue
1
1
Human-Device Interface Problem
1
1
Material Twisted/Bent
1
1
Mechanical Jam
1
1
Mechanics Altered
1
1
Moisture or Humidity Problem
1
1
Disconnection
1
1
Electromagnetic Interference
1
1
Electrical /Electronic Property Problem
1
1
Bent
1
1
Component Falling
1
1
Device Maintenance Issue
1
1
Fungus in Device Environment
1
1
Deformation Due to Compressive Stress
1
1
Contamination /Decontamination Problem
1
1
Detachment of Device or Device Component
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
132
132
Fall
120
120
Bone Fracture(s)
51
51
No Clinical Signs, Symptoms or Conditions
35
35
No Known Impact Or Consequence To Patient
32
32
Limb Fracture
24
24
Injury
18
18
Hip Fracture
17
17
Fracture, Arm
14
14
Bruise/Contusion
13
13
Head Injury
8
8
Damage to Ligament(s)
8
8
Concussion
8
8
Laceration(s)
7
7
Rupture
6
6
Insufficient Information
6
6
Spinal Column Injury
5
5
Pain
3
3
Hematoma
3
3
Contusion
3
3
Joint Dislocation
3
3
Multiple Fractures
2
2
No Code Available
2
2
Neck Pain
2
2
Skull Fracture
2
2
Abrasion
2
2
Tissue Damage
1
1
Physical Entrapment
1
1
Crushing Injury
1
1
Death
1
1
Hemorrhage/Bleeding
1
1
Intracranial Hemorrhage
1
1
No Patient Involvement
1
1
Tissue Breakdown
1
1
Intervertebral Disc Compression or Protrusion
1
1
Muscle/Tendon Damage
1
1
Loss of consciousness
1
1
Tooth Fracture
1
1
Spinal Cord Injury
1
1
Arthralgia
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Bock,Otto,Orthopedic Ind,Inc
II
Dec-16-2009
2
Ossur Engineering, Inc
II
Mar-25-2011
3
Ossur H / F
II
Feb-06-2012
4
Otto Bock Healthcare GmbH
II
Feb-01-2016
5
Otto Bock Healthcare GmbH
II
Jul-24-2015
6
Otto Bock Healthcare Product
II
Mar-01-2018
7
Ottobock Orthopedic Industrie
II
Feb-13-2019
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