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TPLC
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show TPLC since
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Device
pin, fixation, smooth
Regulation Description
Smooth or threaded metallic bone fixation fastener.
Product Code
HTY
Regulation Number
888.3040
Device Class
2
Premarket Reviews
Manufacturer
Decision
4WEB, INC.
SUBSTANTIALLY EQUIVALENT
1
ADDITIVE ORTHOPAEDICS, LLC
SUBSTANTIALLY EQUIVALENT
1
ARTHREX, INC.
SUBSTANTIALLY EQUIVALENT
3
IN2BONES SAS
SUBSTANTIALLY EQUIVALENT
2
METRIC MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
1
NEWCLIP TECHNICS
SUBSTANTIALLY EQUIVALENT
1
ORTHOFIX
SUBSTANTIALLY EQUIVALENT
1
ORTHOFIX SRL
SUBSTANTIALLY EQUIVALENT
1
PARAGON 28
SUBSTANTIALLY EQUIVALENT
1
PRECIFIT MEDICAL LTD
SUBSTANTIALLY EQUIVALENT
1
SPINAL RESOURCES INC
SUBSTANTIALLY EQUIVALENT
1
STRYKER CORP.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2016
128
128
2017
82
82
2018
137
137
2019
222
222
2020
210
210
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
287
287
Break
182
182
Fracture
57
57
Mechanical Jam
44
44
Material Twisted/Bent
18
18
Migration or Expulsion of Device
16
16
Insufficient Information
15
15
Device Operates Differently Than Expected
15
15
Appropriate Term/Code Not Available
13
13
Patient-Device Incompatibility
11
11
Device-Device Incompatibility
11
11
Material Fragmentation
10
10
Entrapment of Device
9
9
Material Deformation
8
8
Physical Resistance/Sticking
8
8
Detachment of Device or Device Component
8
8
Separation Failure
8
8
Tip
8
8
Device Dislodged or Dislocated
7
7
Device Slipped
7
7
Failure to Osseointegrate
7
7
Wire
7
7
Pin
7
7
Difficult to Insert
6
6
Loose or Intermittent Connection
6
6
Difficult to Remove
6
6
Bent
6
6
Component Missing
5
5
Patient Device Interaction Problem
5
5
Suture Thread
5
5
Malposition of Device
5
5
Difficult to Advance
4
4
Improper or Incorrect Procedure or Method
4
4
Material Rupture
4
4
Detachment Of Device Component
4
4
Activation Failure
4
4
Migration
4
4
Expiration Date Error
4
4
Device Expiration Issue
4
4
Overheating of Device
3
3
Naturally Worn
3
3
Guidewire
3
3
Fitting Problem
3
3
Failure to Advance
3
3
Device Displays Incorrect Message
3
3
Material Integrity Problem
3
3
Unstable
2
2
Tear, Rip or Hole in Device Packaging
2
2
Rod
2
2
Delivered as Unsterile Product
2
2
Product Quality Problem
2
2
Positioning Problem
2
2
Unintended Movement
2
2
Switch, Push Button
2
2
Material Protrusion/Extrusion
2
2
Failure to Power Up
2
2
Screw
2
2
Failure to Align
2
2
Defective Device
2
2
Shelf Life Exceeded
2
2
Shipping Damage or Problem
2
2
Smoking
2
2
Use of Device Problem
2
2
Visual Prompts will not Clear
1
1
Microbial Contamination of Device
1
1
Material Separation
1
1
Sparking
1
1
Cut In Material
1
1
Socket
1
1
Loss of or Failure to Bond
1
1
Positioning Failure
1
1
No Display/Image
1
1
Display or Visual Feedback Problem
1
1
Material Puncture/Hole
1
1
Nonstandard Device
1
1
Device Emits Odor
1
1
Fire
1
1
Device Operational Issue
1
1
Difficult to Open or Close
1
1
Packaging Problem
1
1
Physical Property Issue
1
1
Therapeutic or Diagnostic Output Failure
1
1
Torn Material
1
1
Needle
1
1
Missing Value Reason
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Cannula
1
1
Trocar
1
1
Device Fell
1
1
Inadequacy of Device Shape and/or Size
1
1
Sticking
1
1
Device Inoperable
1
1
Unraveled Material
1
1
Component Falling
1
1
Corroded
1
1
Electrical /Electronic Property Problem
1
1
Device Damaged Prior to Use
1
1
Flaked
1
1
Connection Problem
1
1
Device Disinfection Or Sterilization Issue
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
106
106
No Code Available
106
106
Unspecified Infection
101
101
No Known Impact Or Consequence To Patient
101
101
Pain
61
61
Injury
46
46
No Patient Involvement
38
38
Non-union Bone Fracture
34
34
Foreign Body In Patient
34
34
Failure of Implant
33
33
Device Embedded In Tissue or Plaque
32
32
Not Applicable
31
31
Post Operative Wound Infection
27
27
Tissue Damage
27
27
No Information
20
20
Swelling
17
17
Impaired Healing
15
15
Cellulitis
14
14
No Clinical Signs, Symptoms or Conditions
12
12
Bone Fracture(s)
10
10
Inflammation
9
9
Loss of Range of Motion
8
8
Discomfort
7
7
Necrosis
6
6
Joint Disorder
5
5
Thrombosis
5
5
Organ Dehiscence
5
5
Wound Dehiscence
4
4
Patient Problem/Medical Problem
4
4
Nerve Damage
4
4
Bacterial Infection
4
4
Implant Pain
3
3
Pulmonary Embolism
3
3
Arthritis
3
3
Rash
3
3
Fever
3
3
Insufficient Information
3
3
Hypersensitivity/Allergic reaction
3
3
Fracture, Arm
3
3
Hypoesthesia
2
2
Deformity/ Disfigurement
2
2
Osteolysis
2
2
Fluid Discharge
2
2
Irritation
2
2
Cyst(s)
2
2
Erythema
2
2
Reaction
2
2
Adhesion(s)
2
2
Edema
2
2
Complaint, Ill-Defined
2
2
Synovitis
2
2
Pleural Effusion
1
1
Burning Sensation
1
1
Embolus
1
1
Foreign Body Reaction
1
1
Weight Changes
1
1
Inadequate Osseointegration
1
1
Thromboembolism
1
1
Fall
1
1
Fatigue
1
1
Erosion
1
1
Abscess
1
1
Hematoma
1
1
Skin Irritation
1
1
Sweating
1
1
Joint Dislocation
1
1
Malaise
1
1
Rupture
1
1
Ulcer
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Amendia, Inc
II
Dec-22-2016
2
Biomet, Inc.
II
May-26-2016
3
Brasseler USA I Lp
II
Jan-29-2020
4
MicroAire Surgical Instruments, LLC
II
Mar-03-2017
5
Trilliant Surgical, LLC
II
Apr-01-2020
6
Zimmer Biomet, Inc.
II
Jun-01-2018
7
Zimmer Biomet, Inc.
II
Oct-14-2016
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