Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
pin, fixation, threaded
Product Code
JDW
Regulation Number
888.3040
Device Class
2
Premarket Reviews
Manufacturer
Decision
EISERTECH, LLC
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
3
STRYKER GMBH
SUBSTANTIALLY EQUIVALENT
1
SYNTEC SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
TINAVI (ANHUI) MEDICAL TECHNOLOGIES CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
575
575
2020
402
402
2021
168
168
2022
124
124
2023
74
74
2024
23
23
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
871
871
Break
97
97
Insufficient Information
80
80
Fracture
48
48
Migration
43
43
Mechanical Problem
42
42
Patient Device Interaction Problem
30
30
Device Markings/Labelling Problem
23
23
Material Deformation
20
20
Material Fragmentation
18
18
Appropriate Term/Code Not Available
17
17
Loose or Intermittent Connection
15
15
Patient-Device Incompatibility
15
15
Malposition of Device
14
14
Device Dislodged or Dislocated
11
11
Loosening of Implant Not Related to Bone-Ingrowth
11
11
Device-Device Incompatibility
10
10
Inadequacy of Device Shape and/or Size
8
8
Unintended Movement
7
7
Detachment of Device or Device Component
5
5
Naturally Worn
5
5
Entrapment of Device
4
4
Packaging Problem
4
4
Mechanical Jam
4
4
No Apparent Adverse Event
3
3
Device Slipped
3
3
Defective Component
3
3
Loss of Osseointegration
3
3
Material Split, Cut or Torn
3
3
Physical Resistance/Sticking
3
3
Protective Measures Problem
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Human-Device Interface Problem
2
2
Device Contaminated During Manufacture or Shipping
1
1
Mechanics Altered
1
1
Material Twisted/Bent
1
1
Defective Device
1
1
Fitting Problem
1
1
Contamination /Decontamination Problem
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Corroded
1
1
Crack
1
1
Delivered as Unsterile Product
1
1
Peeled/Delaminated
1
1
Difficult to Remove
1
1
Self-Activation or Keying
1
1
Shipping Damage or Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
472
472
Injury
193
193
Post Operative Wound Infection
119
119
No Clinical Signs, Symptoms or Conditions
111
111
No Code Available
73
73
No Known Impact Or Consequence To Patient
73
73
Bacterial Infection
72
72
Non-union Bone Fracture
56
56
Inflammation
52
52
No Information
51
51
Pain
39
39
Failure of Implant
38
38
Insufficient Information
32
32
Erythema
24
24
Nerve Damage
23
23
Bone Fracture(s)
22
22
Foreign Body In Patient
22
22
Deformity/ Disfigurement
20
20
No Consequences Or Impact To Patient
18
18
Loss of Range of Motion
14
14
Irritation
12
12
Device Embedded In Tissue or Plaque
11
11
Malunion of Bone
11
11
Skin Infection
11
11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
10
10
Impaired Healing
10
10
Perforation
9
9
Swelling
9
9
Thrombosis
9
9
Osteomyelitis
9
9
Tissue Breakdown
7
7
Discharge
6
6
Tissue Damage
6
6
Hematoma
6
6
Purulent Discharge
6
6
Arthritis
6
6
Cellulitis
5
5
Ossification
5
5
Hemorrhage/Bleeding
5
5
Ambulation Difficulties
5
5
Fluid Discharge
5
5
Joint Contracture
5
5
Joint Dislocation
4
4
Fall
4
4
Pulmonary Embolism
4
4
Abscess
4
4
Necrosis
4
4
Tingling
3
3
Scar Tissue
3
3
Thrombosis/Thrombus
3
3
No Patient Involvement
2
2
Wound Dehiscence
2
2
Localized Skin Lesion
2
2
Unequal Limb Length
1
1
Swollen Lymph Nodes/Glands
1
1
Drug Resistant Bacterial Infection
1
1
Unspecified Tissue Injury
1
1
External Prosthetic Device Pain
1
1
Implant Pain
1
1
Swelling/ Edema
1
1
Death
1
1
Aneurysm
1
1
Embolism
1
1
Hypersensitivity/Allergic reaction
1
1
Granuloma
1
1
Renal Failure
1
1
Paresis
1
1
Muscular Rigidity
1
1
Numbness
1
1
Fibrosis
1
1
Not Applicable
1
1
Limb Fracture
1
1
Subluxation
1
1
Joint Laxity
1
1
Sepsis
1
1
Rupture
1
1
Hernia
1
1
Ulcer
1
1
Complaint, Ill-Defined
1
1
Hip Fracture
1
1
Fracture, Arm
1
1
Vascular System (Circulation), Impaired
1
1
Pseudoaneurysm
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Orthofix Srl
II
Nov-14-2019
-
-