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TPLC
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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
63
63
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
884
884
Break
102
102
Insufficient Information
80
80
Fracture
57
57
Mechanical Problem
45
45
Migration
45
45
Patient Device Interaction Problem
35
35
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-Device Incompatibility
11
11
Device Dislodged or Dislocated
11
11
Loosening of Implant Not Related to Bone-Ingrowth
11
11
Inadequacy of Device Shape and/or Size
8
8
Unintended Movement
7
7
Naturally Worn
5
5
Entrapment of Device
5
5
Detachment of Device or Device Component
5
5
Mechanical Jam
4
4
Physical Resistance/Sticking
4
4
Packaging Problem
4
4
Loss of Osseointegration
3
3
No Apparent Adverse Event
3
3
Contamination /Decontamination Problem
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Defective Component
3
3
Material Split, Cut or Torn
3
3
Device Slipped
3
3
Material Twisted/Bent
2
2
Separation Failure
2
2
Protective Measures Problem
2
2
Human-Device Interface Problem
2
2
Device Contaminated During Manufacture or Shipping
2
2
Use of Device Problem
1
1
Shipping Damage or Problem
1
1
Mechanics Altered
1
1
Difficult to Remove
1
1
Delivered as Unsterile Product
1
1
Difficult or Delayed Separation
1
1
Defective Device
1
1
Peeled/Delaminated
1
1
Crack
1
1
Activation, Positioning or Separation Problem
1
1
Nonstandard Device
1
1
Connection Problem
1
1
Self-Activation or Keying
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
475
475
Injury
193
193
Post Operative Wound Infection
121
121
No Clinical Signs, Symptoms or Conditions
120
120
Bacterial Infection
78
78
No Code Available
73
73
No Known Impact Or Consequence To Patient
73
73
Non-union Bone Fracture
59
59
Inflammation
53
53
No Information
51
51
Pain
41
41
Failure of Implant
41
41
Insufficient Information
37
37
Foreign Body In Patient
25
25
Erythema
24
24
Nerve Damage
23
23
Bone Fracture(s)
23
23
Deformity/ Disfigurement
20
20
No Consequences Or Impact To Patient
18
18
Loss of Range of Motion
15
15
Malunion of Bone
13
13
Device Embedded In Tissue or Plaque
12
12
Irritation
12
12
Impaired Healing
11
11
Skin Infection
11
11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
11
11
Perforation
11
11
Osteomyelitis
10
10
Thrombosis
9
9
Swelling
9
9
Tissue Breakdown
7
7
Cellulitis
6
6
Purulent Discharge
6
6
Hematoma
6
6
Arthritis
6
6
Discharge
6
6
Tissue Damage
6
6
Ossification
5
5
Ambulation Difficulties
5
5
Fluid Discharge
5
5
Hemorrhage/Bleeding
5
5
Joint Contracture
5
5
Necrosis
4
4
Pulmonary Embolism
4
4
Joint Dislocation
4
4
Fall
4
4
Abscess
4
4
Thrombosis/Thrombus
3
3
Scar Tissue
3
3
Tingling
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Orthofix Srl
II
Nov-14-2019
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