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TPLC
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show TPLC since
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Device
appliance, fixation, nail/blade/plate combination, single component
Product Code
KTW
Regulation Number
888.3030
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADVANCED ORTHOPAEDIC SOLUTIONS, INC
SUBSTANTIALLY EQUIVALENT
1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
SUBSTANTIALLY EQUIVALENT
1
ORTHOFIX SRL
SUBSTANTIALLY EQUIVALENT
1
1. K122541
ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP)
PAONAN BIOTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
PARAGON 28, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
62
62
2015
26
26
2016
41
41
2017
27
27
2018
24
24
2019
11
11
2020
60
60
2021
25
25
2022
50
50
2023
30
30
2024
44
44
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
147
147
Break
117
117
Device-Device Incompatibility
16
16
Patient Device Interaction Problem
16
16
Migration or Expulsion of Device
15
15
Failure to Cut
14
14
Fracture
13
13
Fitting Problem
9
9
Material Twisted/Bent
9
9
Device Operates Differently Than Expected
7
7
Migration
7
7
Material Deformation
7
7
Appropriate Term/Code Not Available
5
5
Unintended Movement
4
4
Failure to Power Up
3
3
Sticking
2
2
Device Dislodged or Dislocated
2
2
Mechanical Jam
2
2
Entrapment of Device
2
2
Deformation Due to Compressive Stress
2
2
Detachment of Device or Device Component
2
2
No Apparent Adverse Event
2
2
Insufficient Information
1
1
Dull, Blunt
1
1
Failure to Align
1
1
Failure to Disconnect
1
1
Operating System Becomes Nonfunctional
1
1
Positioning Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Device Damaged by Another Device
1
1
Use of Device Problem
1
1
Metal Shedding Debris
1
1
Failure to Osseointegrate
1
1
Difficult to Remove
1
1
Device Slipped
1
1
Detachment Of Device Component
1
1
Component Falling
1
1
Crack
1
1
Difficult or Delayed Positioning
1
1
Failure To Adhere Or Bond
1
1
Bent
1
1
Partial Blockage
1
1
Loss of or Failure to Bond
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Failure of Implant
82
82
Pain
59
59
Non-union Bone Fracture
54
54
No Code Available
47
47
Impaired Healing
33
33
Insufficient Information
32
32
No Clinical Signs, Symptoms or Conditions
32
32
No Known Impact Or Consequence To Patient
28
28
Unspecified Infection
26
26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
20
20
Hypersensitivity/Allergic reaction
14
14
Loss of Range of Motion
11
11
Bone Fracture(s)
10
10
Necrosis
10
10
Malunion of Bone
9
9
Unspecified Tissue Injury
4
4
Fall
4
4
Arthritis
4
4
No Consequences Or Impact To Patient
4
4
Nerve Damage
3
3
Post Operative Wound Infection
3
3
Ambulation Difficulties
2
2
Not Applicable
2
2
No Information
2
2
Reaction
2
2
Fracture, Arm
2
2
Swelling
2
2
Osteolysis
2
2
Irritation
2
2
Physical Asymmetry
2
2
Swelling/ Edema
1
1
Implant Pain
1
1
Limb Fracture
1
1
Inflammation
1
1
Erosion
1
1
Discomfort
1
1
Injury
1
1
Hip Fracture
1
1
Seizures
1
1
Seroma
1
1
Skin Erosion
1
1
Spinal Column Injury
1
1
Joint Dislocation
1
1
Sedation
1
1
No Patient Involvement
1
1
Foreign Body In Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Synthes USA (HQ), Inc.
II
Feb-16-2011
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