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TPLC
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show TPLC since
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2024
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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
ARMIS BIOPHARMA, INC.
SUBSTANTIALLY EQUIVALENT
1
ARTHREX INC.
SUBSTANTIALLY EQUIVALENT
2
ELECTRO-SPEC, INC
SUBSTANTIALLY EQUIVALENT
1
IN2BONES USA, LLC
SUBSTANTIALLY EQUIVALENT
1
INTELIVATION
SUBSTANTIALLY EQUIVALENT
1
LIMACORPORATE S.P.A.
SUBSTANTIALLY EQUIVALENT
1
ORTHOPEDIATRICS CORP.
SUBSTANTIALLY EQUIVALENT
1
OSSIO LTD.
SUBSTANTIALLY EQUIVALENT
6
PACIFIC INSTRUMENTS
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
2019
222
222
2020
210
210
2021
148
148
2022
95
95
2023
155
155
2024
57
57
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
338
338
Break
203
203
Fracture
66
66
Detachment of Device or Device Component
44
44
Mechanical Jam
32
32
Material Deformation
20
20
Material Twisted/Bent
20
20
Device-Device Incompatibility
17
17
Migration
16
16
Material Split, Cut or Torn
14
14
Entrapment of Device
14
14
Defective Device
13
13
Insufficient Information
11
11
Physical Resistance/Sticking
11
11
Appropriate Term/Code Not Available
10
10
Device Dislodged or Dislocated
8
8
Material Fragmentation
8
8
Failure to Power Up
8
8
Loose or Intermittent Connection
7
7
Use of Device Problem
7
7
Activation Failure
7
7
Patient Device Interaction Problem
6
6
Migration or Expulsion of Device
6
6
Difficult to Remove
6
6
Improper or Incorrect Procedure or Method
6
6
Device Slipped
5
5
Positioning Problem
5
5
Therapeutic or Diagnostic Output Failure
4
4
Unstable
4
4
Output Problem
4
4
Failure to Advance
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Malposition of Device
3
3
Tear, Rip or Hole in Device Packaging
3
3
Unintended Movement
3
3
Loosening of Implant Not Related to Bone-Ingrowth
3
3
Product Quality Problem
3
3
Material Rupture
3
3
Material Separation
3
3
Material Frayed
3
3
Positioning Failure
2
2
Off-Label Use
2
2
Difficult to Insert
2
2
Delivered as Unsterile Product
2
2
Inadequacy of Device Shape and/or Size
2
2
No Apparent Adverse Event
2
2
Material Protrusion/Extrusion
2
2
Failure to Osseointegrate
2
2
Expiration Date Error
2
2
Separation Failure
2
2
Failure to Cut
2
2
Patient-Device Incompatibility
2
2
Connection Problem
2
2
Device Displays Incorrect Message
2
2
Sparking
1
1
Difficult to Advance
1
1
Failure to Align
1
1
Packaging Problem
1
1
Naturally Worn
1
1
Scratched Material
1
1
Smoking
1
1
Unraveled Material
1
1
Visual Prompts will not Clear
1
1
Device Damaged Prior to Use
1
1
Defective Component
1
1
Component Missing
1
1
Shipping Damage or Problem
1
1
Disconnection
1
1
No Display/Image
1
1
Display or Visual Feedback Problem
1
1
Electrical /Electronic Property Problem
1
1
Flaked
1
1
Contamination
1
1
Corroded
1
1
Image Display Error/Artifact
1
1
Nonstandard Device
1
1
Mechanical Problem
1
1
Separation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
183
183
Unspecified Infection
90
90
Insufficient Information
78
78
Failure of Implant
63
63
No Consequences Or Impact To Patient
59
59
Non-union Bone Fracture
45
45
No Code Available
45
45
Injury
44
44
Swelling/ Edema
42
42
Pain
41
41
No Known Impact Or Consequence To Patient
35
35
Post Operative Wound Infection
33
33
Foreign Body In Patient
31
31
Implant Pain
31
31
Not Applicable
25
25
Tissue Damage
24
24
Discomfort
22
22
Bone Fracture(s)
17
17
No Patient Involvement
15
15
Cellulitis
14
14
Device Embedded In Tissue or Plaque
13
13
Inflammation
10
10
Loss of Range of Motion
10
10
Unspecified Tissue Injury
10
10
Swelling
9
9
Impaired Healing
8
8
Physical Asymmetry
8
8
Skin Inflammation/ Irritation
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Deformity/ Disfigurement
6
6
Nerve Damage
6
6
Bacterial Infection
6
6
Hypersensitivity/Allergic reaction
5
5
Joint Disorder
5
5
No Information
5
5
Organ Dehiscence
5
5
Malunion of Bone
5
5
Unspecified Musculoskeletal problem
5
5
Patient Problem/Medical Problem
4
4
Fall
4
4
Arthritis
3
3
Neuropathy
3
3
Necrosis
3
3
Fracture, Arm
3
3
Hypoesthesia
2
2
Osteolysis
2
2
Synovitis
2
2
Thrombosis
2
2
Limb Fracture
2
2
Joint Laxity
2
2
Sepsis
2
2
Perforation
2
2
Hematoma
2
2
Erythema
2
2
Edema
2
2
Erosion
2
2
Cyst(s)
2
2
Pulmonary Embolism
2
2
Adhesion(s)
2
2
Fluid Discharge
2
2
Muscle/Tendon Damage
1
1
Drug Resistant Bacterial Infection
1
1
Wound Dehiscence
1
1
Abscess
1
1
Purulent Discharge
1
1
Embolus
1
1
Fatigue
1
1
Fever
1
1
Foreign Body Reaction
1
1
Granuloma
1
1
Laceration(s)
1
1
Muscular Rigidity
1
1
Pleural Effusion
1
1
Joint Contracture
1
1
Paresthesia
1
1
Thromboembolism
1
1
Pseudoaneurysm
1
1
Weight Changes
1
1
Paraplegia
1
1
Needle Stick/Puncture
1
1
Urinary Retention
1
1
Hip Fracture
1
1
Rupture
1
1
Ulcer
1
1
Inadequate Pain Relief
1
1
Sweating
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
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