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TPLC
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Device
nail, fixation, bone
Regulation Description
Single/multiple component metallic bone fixation appliances and accessories.
Product Code
JDS
Regulation Number
888.3030
Device Class
2
Premarket Reviews
Manufacturer
Decision
AUXEIN MEDICAL PRIVATE LIMITED
SUBSTANTIALLY EQUIVALENT
1
BIOMET INC.
SUBSTANTIALLY EQUIVALENT
1
NARANG MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW INC.
SUBSTANTIALLY EQUIVALENT
2
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
SYNTHES (USA) PRODUCTS, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
643
643
2021
630
630
2022
589
589
2023
357
357
2024
467
467
2025
47
47
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1110
1110
Device-Device Incompatibility
522
522
Break
454
454
Fracture
113
113
Migration
113
113
Insufficient Information
81
81
Material Deformation
73
73
Manufacturing, Packaging or Shipping Problem
65
65
Material Twisted/Bent
46
46
Detachment of Device or Device Component
42
42
Migration or Expulsion of Device
33
33
Use of Device Problem
19
19
Entrapment of Device
18
18
Loose or Intermittent Connection
18
18
No Apparent Adverse Event
17
17
Crack
16
16
Improper or Incorrect Procedure or Method
14
14
Loosening of Implant Not Related to Bone-Ingrowth
14
14
Device Slipped
13
13
Material Integrity Problem
13
13
Difficult to Advance
12
12
Appropriate Term/Code Not Available
12
12
Failure to Align
11
11
Connection Problem
10
10
Defective Device
9
9
Delivered as Unsterile Product
8
8
Device Dislodged or Dislocated
8
8
Illegible Information
6
6
Device Markings/Labelling Problem
6
6
Naturally Worn
6
6
Malposition of Device
5
5
Component Missing
5
5
Mechanical Jam
4
4
Difficult to Insert
4
4
Nonstandard Device
4
4
Tear, Rip or Hole in Device Packaging
3
3
Scratched Material
3
3
Material Separation
3
3
Packaging Problem
3
3
Unintended Movement
3
3
Positioning Failure
3
3
Contamination /Decontamination Problem
2
2
Product Quality Problem
2
2
Activation, Positioning or Separation Problem
2
2
Patient Device Interaction Problem
2
2
Separation Problem
2
2
Loss of Osseointegration
2
2
Deformation Due to Compressive Stress
2
2
Unsealed Device Packaging
2
2
Mechanical Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
859
859
Non-union Bone Fracture
366
366
Failure of Implant
245
245
Injury
215
215
No Code Available
203
203
Unspecified Infection
198
198
Insufficient Information
197
197
Pain
156
156
Bone Fracture(s)
117
117
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
85
85
Physical Asymmetry
67
67
No Consequences Or Impact To Patient
64
64
Post Operative Wound Infection
50
50
Deformity/ Disfigurement
49
49
Malunion of Bone
48
48
Necrosis
38
38
Discomfort
38
38
No Known Impact Or Consequence To Patient
35
35
Impaired Healing
31
31
Skin Inflammation/ Irritation
29
29
Loss of Range of Motion
29
29
Thrombosis/Thrombus
25
25
Foreign Body In Patient
24
24
Inflammation
20
20
Implant Pain
19
19
Perforation
19
19
Ambulation Difficulties
15
15
Unspecified Tissue Injury
15
15
Nerve Damage
14
14
Fall
13
13
No Patient Involvement
13
13
Hip Fracture
12
12
Tissue Damage
11
11
Hematoma
11
11
No Information
10
10
Muscular Rigidity
9
9
Swelling/ Edema
9
9
Bacterial Infection
9
9
Ossification
8
8
Joint Dislocation
8
8
Device Embedded In Tissue or Plaque
8
8
Limb Fracture
7
7
Fluid Discharge
7
7
Muscle Weakness
6
6
Reaction
6
6
Cellulitis
6
6
Skin Irritation
5
5
Skin Infection
5
5
Osteomyelitis
5
5
Hypersensitivity/Allergic reaction
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
Smith & Nephew Orthopaedics GmbH
II
May-25-2022
2
Smith & Nephew, Inc.
II
Jan-06-2021
3
Smith & Nephew, Inc.
II
Jul-22-2020
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