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TPLC
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show TPLC since
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Device
nail, fixation, bone
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
SYNTHES (USA) PRODUCTS, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
506
506
2017
287
287
2018
320
320
2019
490
490
2020
643
643
2021
630
630
2022
598
598
2023
357
357
2024
278
278
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1718
1718
Break
717
717
Device-Device Incompatibility
495
495
Insufficient Information
216
216
Fracture
205
205
Migration
118
118
Migration or Expulsion of Device
93
93
Material Deformation
76
76
Manufacturing, Packaging or Shipping Problem
65
65
Material Twisted/Bent
48
48
Detachment of Device or Device Component
42
42
Appropriate Term/Code Not Available
40
40
Failure to Align
36
36
Device Operates Differently Than Expected
34
34
Unintended Movement
33
33
Loose or Intermittent Connection
29
29
No Apparent Adverse Event
29
29
Device Slipped
25
25
Loosening of Implant Not Related to Bone-Ingrowth
21
21
Entrapment of Device
21
21
Connection Problem
19
19
Use of Device Problem
19
19
Improper or Incorrect Procedure or Method
17
17
Mechanical Jam
17
17
Crack
16
16
Device Dislodged or Dislocated
13
13
Fitting Problem
13
13
Difficult to Advance
13
13
Material Integrity Problem
13
13
Difficult to Remove
12
12
Bent
12
12
Material Fragmentation
10
10
Malposition of Device
10
10
Patient-Device Incompatibility
9
9
Defective Device
9
9
Device Difficult to Maintain
8
8
Device Markings/Labelling Problem
8
8
Delivered as Unsterile Product
7
7
Component Missing
6
6
Sticking
6
6
Difficult to Insert
6
6
Naturally Worn
6
6
Patient Device Interaction Problem
6
6
Mechanical Problem
5
5
Inadequacy of Device Shape and/or Size
5
5
Positioning Problem
4
4
Failure To Adhere Or Bond
4
4
Nonstandard Device
4
4
Positioning Failure
3
3
Separation Failure
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
782
782
No Clinical Signs, Symptoms or Conditions
764
764
Non-union Bone Fracture
599
599
Unspecified Infection
396
396
Injury
396
396
Failure of Implant
388
388
Pain
351
351
No Consequences Or Impact To Patient
209
209
Bone Fracture(s)
190
190
No Known Impact Or Consequence To Patient
147
147
Impaired Healing
142
142
Insufficient Information
132
132
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
85
85
Discomfort
71
71
Physical Asymmetry
66
66
Necrosis
58
58
No Information
55
55
Post Operative Wound Infection
54
54
Deformity/ Disfigurement
49
49
Loss of Range of Motion
47
47
Foreign Body In Patient
45
45
Malunion of Bone
41
41
No Patient Involvement
33
33
Skin Inflammation/ Irritation
29
29
Inflammation
27
27
Thrombosis/Thrombus
25
25
Device Embedded In Tissue or Plaque
20
20
Fall
20
20
Perforation
20
20
Tissue Damage
19
19
Nerve Damage
19
19
Hip Fracture
17
17
Ambulation Difficulties
16
16
Unspecified Tissue Injury
15
15
Hypersensitivity/Allergic reaction
14
14
Not Applicable
14
14
Irritation
13
13
Patient Problem/Medical Problem
13
13
Hematoma
13
13
Implant Pain
12
12
Bacterial Infection
11
11
Sedation
10
10
Joint Dislocation
10
10
Swelling/ Edema
9
9
Cellulitis
9
9
Ossification
8
8
Reaction
8
8
Muscular Rigidity
8
8
Skin Irritation
8
8
Death
7
7
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
4
Smith & Nephew, Inc.
II
Nov-16-2017
5
Zimmer Biomet, Inc.
II
Mar-27-2017
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