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TPLC
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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
CONVENTUS ORTHOPAEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
NARANG MEDICAL LTD.
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW INC.
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
SYNTHES (USA)
SUBSTANTIALLY EQUIVALENT
1
1. K111667
SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS
SYNTHES (USA) PRODUCTS, LLC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
389
389
2015
316
316
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
120
120
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1892
1892
Break
790
790
Device-Device Incompatibility
450
450
Insufficient Information
253
253
Fracture
230
230
Migration or Expulsion of Device
126
126
Migration
113
113
Device Operates Differently Than Expected
96
96
Material Deformation
69
69
Manufacturing, Packaging or Shipping Problem
65
65
Appropriate Term/Code Not Available
58
58
Failure to Align
57
57
Material Twisted/Bent
47
47
Fitting Problem
41
41
Unintended Movement
40
40
Mechanical Jam
38
38
Device Dislodged or Dislocated
33
33
Detachment of Device or Device Component
33
33
Loose or Intermittent Connection
30
30
No Apparent Adverse Event
29
29
Device Slipped
27
27
Difficult to Remove
24
24
Entrapment of Device
21
21
Loosening of Implant Not Related to Bone-Ingrowth
21
21
Bent
20
20
Connection Problem
20
20
Improper or Incorrect Procedure or Method
18
18
Use of Device Problem
18
18
Sticking
17
17
Crack
17
17
Difficult to Insert
16
16
Failure to Osseointegrate
16
16
Difficult to Advance
15
15
Material Fragmentation
14
14
Failure To Adhere Or Bond
13
13
Malposition of Device
12
12
Device Markings/Labelling Problem
11
11
Material Integrity Problem
11
11
Patient-Device Incompatibility
9
9
Defective Device
9
9
Material Protrusion/Extrusion
8
8
Device Difficult to Maintain
8
8
Compatibility Problem
7
7
Positioning Problem
7
7
Inadequacy of Device Shape and/or Size
7
7
Separation Failure
7
7
Component Missing
7
7
Mechanical Problem
7
7
Difficult To Position
7
7
Naturally Worn
6
6
Patient Device Interaction Problem
6
6
Packaging Problem
5
5
Delivered as Unsterile Product
5
5
Unstable
5
5
Contamination /Decontamination Problem
4
4
Nonstandard Device
4
4
Collapse
4
4
Device Damaged by Another Device
4
4
Scratched Material
3
3
Device Handling Problem
3
3
Incomplete or Inadequate Connection
3
3
Degraded
3
3
Material Separation
3
3
Loss of Osseointegration
3
3
Incomplete or Missing Packaging
2
2
Tear, Rip or Hole in Device Packaging
2
2
Failure to Advance
2
2
Component or Accessory Incompatibility
2
2
Activation, Positioning or Separation Problem
2
2
Device Operational Issue
2
2
Product Quality Problem
2
2
Positioning Failure
2
2
Detachment Of Device Component
2
2
Partial Blockage
2
2
Loss of or Failure to Bond
2
2
Material Discolored
2
2
Separation Problem
2
2
Physical Resistance/Sticking
2
2
Component Misassembled
2
2
Mechanics Altered
2
2
Therapeutic or Diagnostic Output Failure
1
1
Torn Material
1
1
Extrusion
1
1
Device Contamination with Chemical or Other Material
1
1
Material Distortion
1
1
Material Split, Cut or Torn
1
1
Noise, Audible
1
1
Misassembly by Users
1
1
Osseointegration Problem
1
1
Difficult or Delayed Separation
1
1
Premature Separation
1
1
Thickening of Material
1
1
Material Disintegration
1
1
Hole In Material
1
1
Device Expiration Issue
1
1
Component Incompatible
1
1
Disassembly
1
1
Off-Label Use
1
1
Material Puncture/Hole
1
1
Shelf Life Exceeded
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
920
920
No Clinical Signs, Symptoms or Conditions
696
696
Non-union Bone Fracture
654
654
Failure of Implant
468
468
Pain
439
439
Unspecified Infection
428
428
Injury
400
400
No Known Impact Or Consequence To Patient
279
279
Bone Fracture(s)
224
224
No Consequences Or Impact To Patient
223
223
Impaired Healing
212
212
Insufficient Information
112
112
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
85
85
Discomfort
84
84
No Information
72
72
Necrosis
65
65
Post Operative Wound Infection
57
57
Physical Asymmetry
56
56
Loss of Range of Motion
55
55
Foreign Body In Patient
48
48
Deformity/ Disfigurement
46
46
Sedation
42
42
Malunion of Bone
38
38
No Patient Involvement
35
35
Fall
31
31
Device Embedded In Tissue or Plaque
30
30
Skin Inflammation/ Irritation
27
27
Tissue Damage
27
27
Thrombosis/Thrombus
24
24
Irritation
23
23
Inflammation
22
22
Nerve Damage
22
22
Perforation
22
22
Hip Fracture
19
19
Ambulation Difficulties
18
18
Hematoma
16
16
Reaction
15
15
Not Applicable
14
14
Hypersensitivity/Allergic reaction
14
14
Patient Problem/Medical Problem
13
13
Unspecified Tissue Injury
13
13
Ossification
12
12
Skin Irritation
11
11
Joint Dislocation
11
11
Bacterial Infection
10
10
Cellulitis
9
9
Implant Pain
8
8
Limb Fracture
7
7
Swelling/ Edema
7
7
Death
7
7
Swelling
7
7
Muscular Rigidity
7
7
Fracture, Arm
6
6
Paralysis
6
6
Inadequate Osseointegration
6
6
Skin Infection
5
5
Rash
5
5
Sepsis
5
5
Pulmonary Embolism
5
5
Abscess
4
4
Wound Dehiscence
4
4
Arthritis
4
4
Muscle Weakness
4
4
Thrombosis
4
4
Unequal Limb Length
4
4
Joint Laxity
4
4
Fluid Discharge
4
4
Blood Loss
3
3
Numbness
3
3
Hypoesthesia
3
3
Arthralgia
3
3
Infiltration into Tissue
3
3
Fever
3
3
Calcium Deposits/Calcification
3
3
Anemia
2
2
Hemorrhage/Bleeding
2
2
Itching Sensation
2
2
Laceration(s)
2
2
Weakness
2
2
Therapeutic Response, Decreased
2
2
Ulcer
2
2
Skin Erosion
2
2
Scar Tissue
2
2
Pocket Erosion
2
2
Neuropathy
2
2
Confusion/ Disorientation
2
2
Limited Mobility Of The Implanted Joint
2
2
Muscle/Tendon Damage
2
2
Osteomyelitis
2
2
Vertebral Fracture
2
2
Embolism/Embolus
2
2
Movement Disorder
1
1
Hyperextension
1
1
Joint Contracture
1
1
Skin Disorders
1
1
Fibrosis
1
1
Pseudoaneurysm
1
1
Low Oxygen Saturation
1
1
Osteopenia/ Osteoporosis
1
1
Intraoperative Pain
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Smith & Nephew Inc
II
May-20-2014
2
Smith & Nephew Inc
II
Mar-13-2013
3
Smith & Nephew Orthopaedics GmbH
II
May-25-2022
4
Smith & Nephew, Inc.
II
Jan-06-2021
5
Smith & Nephew, Inc.
II
Jul-22-2020
6
Smith & Nephew, Inc.
II
Nov-16-2017
7
Smith & Nephew, Inc.
II
Aug-17-2014
8
Stryker Howmedica Osteonics Corp.
II
Jun-01-2009
9
Synthes (USA) Products LLC
II
Nov-26-2013
10
Synthes USA (HQ), Inc.
II
May-07-2010
11
Synthes USA HQ, Inc.
II
Nov-27-2013
12
Synthes, Inc.
II
Jul-08-2015
13
Zimmer Biomet, Inc.
II
Mar-27-2017
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