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TPLC
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show TPLC since
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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
IN2BONES SAS
SUBSTANTIALLY EQUIVALENT
1
IN2BONES USA, LLC
SUBSTANTIALLY EQUIVALENT
1
LIMACORPORATE S.P.A.
SUBSTANTIALLY EQUIVALENT
1
NEWCLIP TECHNICS
SUBSTANTIALLY EQUIVALENT
1
ORTHOPEDIATRICS CORP.
SUBSTANTIALLY EQUIVALENT
1
OSSIO LTD.
SUBSTANTIALLY EQUIVALENT
4
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
XIROS LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
138
138
2019
222
222
2020
210
210
2021
149
149
2022
95
95
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
344
344
Break
173
173
Fracture
63
63
Mechanical Jam
44
44
Material Twisted/Bent
19
19
Insufficient Information
18
18
Device-Device Incompatibility
14
14
Entrapment of Device
14
14
Detachment of Device or Device Component
13
13
Appropriate Term/Code Not Available
12
12
Material Deformation
11
11
Migration
11
11
Patient-Device Incompatibility
10
10
Separation Failure
10
10
Loose or Intermittent Connection
9
9
Physical Resistance/Sticking
9
9
Material Fragmentation
7
7
Migration or Expulsion of Device
7
7
Device Operates Differently Than Expected
7
7
Device Slipped
6
6
Improper or Incorrect Procedure or Method
6
6
Use of Device Problem
5
5
Difficult to Remove
5
5
Device Dislodged or Dislocated
5
5
Malposition of Device
5
5
Patient Device Interaction Problem
5
5
Positioning Problem
5
5
Material Split, Cut or Torn
5
5
Therapeutic or Diagnostic Output Failure
4
4
Activation Failure
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Difficult to Advance
4
4
Expiration Date Error
4
4
Failure to Power Up
4
4
Unstable
4
4
Product Quality Problem
3
3
Defective Device
3
3
Device Displays Incorrect Message
3
3
Unintended Movement
3
3
Output Problem
3
3
Naturally Worn
2
2
Material Protrusion/Extrusion
2
2
Failure to Advance
2
2
Component Missing
2
2
Material Rupture
2
2
Inadequacy of Device Shape and/or Size
2
2
Failure to Osseointegrate
2
2
Difficult to Insert
2
2
Delivered as Unsterile Product
2
2
Nonstandard Device
1
1
Image Display Error/Artifact
1
1
Mechanical Problem
1
1
Device Expiration Issue
1
1
Flaked
1
1
Bent
1
1
Partial Blockage
1
1
Corroded
1
1
Positioning Failure
1
1
Disconnection
1
1
No Display/Image
1
1
Display or Visual Feedback Problem
1
1
Electrical /Electronic Property Problem
1
1
Visual Prompts will not Clear
1
1
Device Damaged Prior to Use
1
1
Microbial Contamination of 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
Failure to Cut
1
1
Difficult to Open or Close
1
1
Connection Problem
1
1
Packaging Problem
1
1
No Apparent Adverse Event
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Device Fell
1
1
Separation Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
97
97
Unspecified Infection
97
97
No Clinical Signs, Symptoms or Conditions
75
75
No Code Available
62
62
Pain
51
51
Injury
45
45
No Known Impact Or Consequence To Patient
42
42
Swelling/ Edema
42
42
Failure of Implant
40
40
Non-union Bone Fracture
38
38
Insufficient Information
35
35
Foreign Body In Patient
33
33
Not Applicable
31
31
Implant Pain
30
30
Post Operative Wound Infection
27
27
Tissue Damage
26
26
No Patient Involvement
25
25
Discomfort
25
25
Device Embedded In Tissue or Plaque
20
20
Cellulitis
14
14
Swelling
14
14
Impaired Healing
12
12
Bone Fracture(s)
10
10
No Information
9
9
Unspecified Tissue Injury
9
9
Loss of Range of Motion
9
9
Inflammation
9
9
Necrosis
7
7
Joint Disorder
5
5
Organ Dehiscence
5
5
Thrombosis
5
5
Nerve Damage
5
5
Physical Asymmetry
5
5
Deformity/ Disfigurement
4
4
Unspecified Musculoskeletal problem
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
4
4
Patient Problem/Medical Problem
4
4
Bacterial Infection
3
3
Malunion of Bone
3
3
Skin Inflammation/ Irritation
3
3
Hypersensitivity/Allergic reaction
3
3
Fall
3
3
Pulmonary Embolism
3
3
Arthritis
3
3
Wound Dehiscence
3
3
Erythema
3
3
Fracture, Arm
3
3
Neuropathy
2
2
Rash
2
2
Sepsis
2
2
Synovitis
2
2
Adhesion(s)
2
2
Erosion
2
2
Cyst(s)
2
2
Fluid Discharge
2
2
Hypoesthesia
2
2
Osteolysis
2
2
Joint Laxity
2
2
Edema
2
2
Foreign Body Reaction
1
1
Muscular Rigidity
1
1
Weight Changes
1
1
Thromboembolism
1
1
Joint Contracture
1
1
Hematoma
1
1
Irritation
1
1
Embolus
1
1
Laceration(s)
1
1
Pleural Effusion
1
1
Needle Stick/Puncture
1
1
Skin Irritation
1
1
Perforation
1
1
Fatigue
1
1
Fever
1
1
Abscess
1
1
Joint Dislocation
1
1
Sweating
1
1
Rupture
1
1
Ulcer
1
1
Hip Fracture
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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