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TPLC
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show TPLC since
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Device
washer, bolt nut
Product Code
HTN
Regulation Number
888.3030
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACUMED LLC
SUBSTANTIALLY EQUIVALENT
1
AKROS MEDICAL
SUBSTANTIALLY EQUIVALENT
3
ARTHREX INC.
SUBSTANTIALLY EQUIVALENT
5
ARTHROSURFACE, INC
SUBSTANTIALLY EQUIVALENT
1
CC-INSTRUMENTS INC
SUBSTANTIALLY EQUIVALENT
1
CONMED CORPORATION
SUBSTANTIALLY EQUIVALENT
2
1. K190516
MicroLink All-Suture Button Fixation System (Radio
...
2. K190582
MicroLink All-Suture Button Fixation System (Radio
...
CORIN USA
SUBSTANTIALLY EQUIVALENT
1
CYCLA ORTHOPEDICS LTD
SUBSTANTIALLY EQUIVALENT
1
GM DOS REIS INDUSTRIA E COMERCIO LTDA
SUBSTANTIALLY EQUIVALENT
1
IN2BONES USA, LLC
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MORTISE MEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
ORTHOPAEDIC IMPLANT COMPANY
SUBSTANTIALLY EQUIVALENT
1
PANTHER ORTHOPEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
SMITH AND NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
TRIMED, INC.
SUBSTANTIALLY EQUIVALENT
1
WRIGHT MEDICAL TECHNOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
1
XIROS LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
30
30
2018
47
47
2019
52
52
2020
81
81
2021
148
148
2022
85
85
2023
108
108
2024
67
67
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
233
233
Adverse Event Without Identified Device or Use Problem
153
153
Device-Device Incompatibility
28
28
Appropriate Term/Code Not Available
22
22
Device Dislodged or Dislocated
18
18
Migration
15
15
Patient Device Interaction Problem
15
15
Entrapment of Device
14
14
Detachment of Device or Device Component
13
13
Difficult to Advance
13
13
Device Slipped
12
12
Fracture
9
9
Insufficient Information
8
8
Material Split, Cut or Torn
8
8
Physical Resistance/Sticking
7
7
Material Separation
7
7
Migration or Expulsion of Device
5
5
Defective Device
5
5
Patient-Device Incompatibility
5
5
Failure to Advance
5
5
Material Twisted/Bent
5
5
Use of Device Problem
4
4
Difficult To Position
4
4
Difficult to Remove
3
3
Improper or Incorrect Procedure or Method
3
3
Device Markings/Labelling Problem
3
3
Device Operates Differently Than Expected
3
3
Expulsion
3
3
No Apparent Adverse Event
3
3
Activation, Positioning or Separation Problem
2
2
Activation Problem
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Expiration Date Error
2
2
Material Integrity Problem
2
2
Material Protrusion/Extrusion
2
2
Output Problem
2
2
Positioning Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Component Missing
2
2
Material Fragmentation
2
2
Loose or Intermittent Connection
2
2
Mechanical Problem
1
1
Detachment Of Device Component
1
1
Use of Incorrect Control/Treatment Settings
1
1
Knotted
1
1
Material Rupture
1
1
Inadequacy of Device Shape and/or Size
1
1
Off-Label Use
1
1
Delivered as Unsterile Product
1
1
Unsealed Device Packaging
1
1
Failure to Align
1
1
Fitting Problem
1
1
Stretched
1
1
Unraveled Material
1
1
Unstable
1
1
Device Damaged by Another Device
1
1
Contamination /Decontamination Problem
1
1
Delivery System Failure
1
1
Misassembly by Users
1
1
Packaging Problem
1
1
Naturally Worn
1
1
Compatibility Problem
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Material Deformation
1
1
Separation Problem
1
1
Device Handling Problem
1
1
Noise, Audible
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
194
194
Insufficient Information
80
80
Pain
68
68
No Code Available
66
66
Failure of Implant
41
41
Unspecified Infection
30
30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
29
29
Foreign Body In Patient
28
28
Non-union Bone Fracture
25
25
No Known Impact Or Consequence To Patient
23
23
No Consequences Or Impact To Patient
21
21
Bone Fracture(s)
12
12
Injury
10
10
No Information
10
10
Joint Dislocation
8
8
Necrosis
7
7
Hypersensitivity/Allergic reaction
7
7
Swelling
6
6
Impaired Healing
6
6
Device Embedded In Tissue or Plaque
6
6
Post Operative Wound Infection
5
5
Osteolysis
5
5
Loss of Range of Motion
5
5
Implant Pain
4
4
Physical Asymmetry
4
4
Limited Mobility Of The Implanted Joint
3
3
Discomfort
3
3
Reaction
3
3
Foreign Body Reaction
3
3
Bacterial Infection
3
3
Fatigue
2
2
Wound Dehiscence
2
2
Tissue Damage
2
2
Nerve Damage
2
2
Inflammation
2
2
Damage to Ligament(s)
2
2
Anxiety
2
2
Distress
2
2
Arthralgia
2
2
No Patient Involvement
2
2
Not Applicable
2
2
Swelling/ Edema
2
2
Limb Fracture
1
1
Patient Problem/Medical Problem
1
1
Osteopenia/ Osteoporosis
1
1
Alteration In Body Temperature
1
1
Complaint, Ill-Defined
1
1
Numbness
1
1
Sweating
1
1
Needle Stick/Puncture
1
1
Palpitations
1
1
Sleep Dysfunction
1
1
Weight Changes
1
1
Muscular Rigidity
1
1
Pleural Effusion
1
1
Tinnitus
1
1
Rash
1
1
Scar Tissue
1
1
Increased Sensitivity
1
1
Abscess
1
1
Arthritis
1
1
Autoimmune Disorder
1
1
Headache
1
1
Erosion
1
1
Bradycardia
1
1
Cyst(s)
1
1
Purulent Discharge
1
1
Edema
1
1
Erythema
1
1
Fall
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
TriMed Inc.
II
Feb-07-2023
2
Zimmer Biomet, Inc.
II
Nov-07-2019
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