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TPLC
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show TPLC since
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2023
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Device
pin, fixation, smooth
Product Code
HTY
Regulation Number
888.3040
Device Class
2
Premarket Reviews
Manufacturer
Decision
4WEB MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
4WEB, INC.
SUBSTANTIALLY EQUIVALENT
1
A.M. SURGICAL, INC
SUBSTANTIALLY EQUIVALENT
1
ARMIS BIOPHARMA, INC.
SUBSTANTIALLY EQUIVALENT
1
ARTHREX INC.
SUBSTANTIALLY EQUIVALENT
2
ELECTRO-SPEC, INC
SUBSTANTIALLY EQUIVALENT
1
IN2BONES SAS
SUBSTANTIALLY EQUIVALENT
1
IN2BONES USA, LLC
SUBSTANTIALLY EQUIVALENT
1
INTELIVATION
SUBSTANTIALLY EQUIVALENT
1
LIMACORPORATE S.P.A.
SUBSTANTIALLY EQUIVALENT
1
NEWCLIP TECHNICS
SUBSTANTIALLY EQUIVALENT
1
ORTHOPEDIATRICS CORP.
SUBSTANTIALLY EQUIVALENT
1
OSSIO LTD.
SUBSTANTIALLY EQUIVALENT
5
PACIFIC INSTRUMENTS
SUBSTANTIALLY EQUIVALENT
1
PARAGON 28
SUBSTANTIALLY EQUIVALENT
1
PARAGON 28, INC.
SUBSTANTIALLY EQUIVALENT
1
RESTOR3D
SUBSTANTIALLY EQUIVALENT
1
SKELETAL DYNAMICS, INC.
SUBSTANTIALLY EQUIVALENT
1
STRYKER GMBH
SUBSTANTIALLY EQUIVALENT
1
TYBER MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
XIROS LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
138
138
2019
222
222
2020
210
210
2021
148
148
2022
95
95
2023
85
85
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
360
360
Break
209
209
Fracture
71
71
Mechanical Jam
43
43
Insufficient Information
19
19
Material Twisted/Bent
19
19
Migration
17
17
Detachment of Device or Device Component
16
16
Entrapment of Device
16
16
Device-Device Incompatibility
15
15
Appropriate Term/Code Not Available
12
12
Physical Resistance/Sticking
11
11
Material Deformation
11
11
Separation Failure
10
10
Patient-Device Incompatibility
10
10
Loose or Intermittent Connection
9
9
Material Fragmentation
8
8
Migration or Expulsion of Device
7
7
Device Operates Differently Than Expected
7
7
Patient Device Interaction Problem
7
7
Device Dislodged or Dislocated
6
6
Improper or Incorrect Procedure or Method
6
6
Device Slipped
6
6
Use of Device Problem
5
5
Failure to Power Up
5
5
Malposition of Device
5
5
Difficult to Advance
5
5
Positioning Problem
5
5
Activation Failure
5
5
Material Split, Cut or Torn
5
5
Therapeutic or Diagnostic Output Failure
4
4
Output Problem
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Unstable
4
4
Defective Device
4
4
Failure to Advance
4
4
Expiration Date Error
4
4
Difficult to Remove
4
4
Product Quality Problem
3
3
Device Displays Incorrect Message
3
3
Unintended Movement
3
3
Loosening of Implant Not Related to Bone-Ingrowth
3
3
Naturally Worn
2
2
Material Protrusion/Extrusion
2
2
Failure to Cut
2
2
Component Missing
2
2
Inadequacy of Device Shape and/or Size
2
2
Off-Label Use
2
2
Failure to Osseointegrate
2
2
Material Rupture
2
2
Difficult to Insert
2
2
Delivered as Unsterile Product
2
2
Positioning Failure
2
2
Disconnection
1
1
No Display/Image
1
1
Display or Visual Feedback Problem
1
1
Electrical /Electronic Property Problem
1
1
Contamination
1
1
Corroded
1
1
Bent
1
1
Partial Blockage
1
1
Material Frayed
1
1
Image Display Error/Artifact
1
1
Mechanical Problem
1
1
Device Expiration Issue
1
1
Flaked
1
1
Nonstandard Device
1
1
Material Separation
1
1
Shelf Life Exceeded
1
1
Shipping Damage or Problem
1
1
Smoking
1
1
Unraveled Material
1
1
Tear, Rip or Hole in Device Packaging
1
1
Failure to Align
1
1
Visual Prompts will not Clear
1
1
Device Damaged Prior to Use
1
1
Microbial Contamination of Device
1
1
Sparking
1
1
Connection Problem
1
1
Difficult to Open or Close
1
1
Packaging Problem
1
1
No Apparent Adverse Event
1
1
Scratched Material
1
1
Device Fell
1
1
Separation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
109
109
Unspecified Infection
100
100
No Consequences Or Impact To Patient
97
97
No Code Available
62
62
Pain
56
56
Failure of Implant
52
52
Non-union Bone Fracture
46
46
Injury
45
45
Insufficient Information
45
45
Swelling/ Edema
42
42
No Known Impact Or Consequence To Patient
42
42
Foreign Body In Patient
37
37
Post Operative Wound Infection
33
33
Not Applicable
31
31
Implant Pain
31
31
Discomfort
26
26
Tissue Damage
26
26
No Patient Involvement
25
25
Device Embedded In Tissue or Plaque
21
21
Bone Fracture(s)
19
19
Cellulitis
14
14
Impaired Healing
14
14
Swelling
14
14
Inflammation
10
10
Loss of Range of Motion
10
10
Unspecified Tissue Injury
10
10
No Information
9
9
Physical Asymmetry
8
8
Necrosis
7
7
Nerve Damage
7
7
Bacterial Infection
6
6
Deformity/ Disfigurement
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Skin Inflammation/ Irritation
6
6
Unspecified Musculoskeletal problem
5
5
Malunion of Bone
5
5
Joint Disorder
5
5
Thrombosis
5
5
Organ Dehiscence
5
5
Patient Problem/Medical Problem
4
4
Fall
4
4
Hypersensitivity/Allergic reaction
4
4
Erythema
3
3
Neuropathy
3
3
Wound Dehiscence
3
3
Pulmonary Embolism
3
3
Arthritis
3
3
Fracture, Arm
3
3
Hypoesthesia
2
2
Osteolysis
2
2
Synovitis
2
2
Adhesion(s)
2
2
Erosion
2
2
Cyst(s)
2
2
Edema
2
2
Perforation
2
2
Rash
2
2
Sepsis
2
2
Hematoma
2
2
Limb Fracture
2
2
Joint Laxity
2
2
Fluid Discharge
2
2
Drug Resistant Bacterial Infection
1
1
Joint Contracture
1
1
Muscle/Tendon Damage
1
1
Irritation
1
1
Laceration(s)
1
1
Muscular Rigidity
1
1
Skin Irritation
1
1
Pleural Effusion
1
1
Embolus
1
1
Granuloma
1
1
Fatigue
1
1
Fever
1
1
Foreign Body Reaction
1
1
Purulent Discharge
1
1
Abscess
1
1
Urinary Retention
1
1
Rupture
1
1
Ulcer
1
1
Joint Dislocation
1
1
Hip Fracture
1
1
Paresthesia
1
1
Pseudoaneurysm
1
1
Weight Changes
1
1
Thromboembolism
1
1
Inadequate Pain Relief
1
1
Sweating
1
1
Paraplegia
1
1
Needle Stick/Puncture
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Brasseler USA I Lp
II
Jan-29-2020
2
Brasseler USA, Medical L.L.C.
II
Mar-01-2022
3
Paragon 28, Inc.
II
Jul-27-2022
4
Stryker GmbH
II
Apr-27-2022
5
Trilliant Surgical, LLC
II
Apr-01-2020
6
Zimmer Biomet, Inc.
II
Jun-01-2018
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