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TPLC
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show TPLC since
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2024
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Device
screw, fixation, intraosseous
Product Code
DZL
Regulation Number
872.4880
Device Class
2
Premarket Reviews
Manufacturer
Decision
DENTIS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
HAGER & MEISINGER GMBH
SUBSTANTIALLY EQUIVALENT
1
1. K201210
The Micro Screw System, Micro Screw System Basic
NEOSS LIMITED
SUBSTANTIALLY EQUIVALENT
1
OSSTEM IMPLANT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
OSSTEM IMPLANT CO., LTD..
SUBSTANTIALLY EQUIVALENT
1
STRYKER LEIBINGER GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
50
50
2020
85
85
2021
55
55
2022
162
162
2023
100
100
2024
29
29
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
152
152
Adverse Event Without Identified Device or Use Problem
72
72
Fracture
66
66
Physical Resistance/Sticking
44
44
Patient Device Interaction Problem
41
41
Mechanical Jam
23
23
Entrapment of Device
10
10
Nonstandard Device
10
10
Manufacturing, Packaging or Shipping Problem
9
9
Material Twisted/Bent
9
9
Difficult to Advance
7
7
Unintended Movement
7
7
Migration
5
5
Signal Artifact/Noise
5
5
Patient-Device Incompatibility
4
4
Naturally Worn
4
4
Detachment of Device or Device Component
3
3
Device Dislodged or Dislocated
3
3
Crack
3
3
Off-Label Use
3
3
Migration or Expulsion of Device
2
2
Improper or Incorrect Procedure or Method
2
2
Difficult or Delayed Activation
2
2
Failure to Fire
2
2
Device-Device Incompatibility
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Activation Failure
2
2
Firing Problem
2
2
Premature Separation
1
1
Noise, Audible
1
1
No Apparent Adverse Event
1
1
Failure to Eject
1
1
Device Contaminated During Manufacture or Shipping
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Malposition of Device
1
1
Defective Device
1
1
Component Missing
1
1
Failure to Align
1
1
Misassembled
1
1
Device Slipped
1
1
Use of Device Problem
1
1
Difficult or Delayed Positioning
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
201
201
Foreign Body In Patient
49
49
No Consequences Or Impact To Patient
48
48
No Information
36
36
Insufficient Information
31
31
Unspecified Infection
23
23
No Code Available
21
21
No Known Impact Or Consequence To Patient
16
16
Non-union Bone Fracture
16
16
Discomfort
15
15
Pain
10
10
Failure of Implant
10
10
Hypersensitivity/Allergic reaction
8
8
Unspecified Musculoskeletal problem
8
8
Nerve Damage
8
8
Device Embedded In Tissue or Plaque
4
4
Loss of consciousness
4
4
Fatigue
4
4
No Patient Involvement
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Post Operative Wound Infection
2
2
Sleep Dysfunction
2
2
Physical Asymmetry
2
2
Swelling/ Edema
2
2
Difficulty Chewing
2
2
Injury
2
2
Impaired Healing
1
1
Limited Mobility Of The Implanted Joint
1
1
Decreased Sensitivity
1
1
Fluid Discharge
1
1
Bone Fracture(s)
1
1
Increased Sensitivity
1
1
Inflammation
1
1
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