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TPLC
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show TPLC since
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Device
screw, fixation, intraosseous
Product Code
DZL
Regulation Number
872.4880
Device Class
2
Premarket Reviews
Manufacturer
Decision
HAGER & MEISINGER GMBH
SUBSTANTIALLY EQUIVALENT
1
INTRA-LOCK INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
1
NEOBIOTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
NEOSS LIMITED
SUBSTANTIALLY EQUIVALENT
1
OSSTEM IMPLANT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
OSSTEM IMPLANT CO., LTD..
SUBSTANTIALLY EQUIVALENT
1
SALVIN DENTAL SPECIALTIES
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2017
74
74
2018
57
57
2019
50
50
2020
85
85
2021
55
55
2022
62
62
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
160
160
Fracture
65
65
Adverse Event Without Identified Device or Use Problem
50
50
Physical Resistance/Sticking
33
33
Mechanical Jam
20
20
Material Fragmentation
11
11
Unintended Movement
8
8
Difficult to Advance
5
5
Use of Device Problem
5
5
Naturally Worn
4
4
Material Twisted/Bent
4
4
Entrapment of Device
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Patient-Device Incompatibility
3
3
Detachment of Device or Device Component
3
3
Difficult or Delayed Activation
2
2
Failure to Fire
2
2
Improper or Incorrect Procedure or Method
2
2
Material Deformation
2
2
Device Dislodged or Dislocated
2
2
Device-Device Incompatibility
2
2
Migration or Expulsion of Device
2
2
Difficult to Remove
2
2
Retraction Problem
2
2
Material Rupture
2
2
Detachment Of Device Component
2
2
Crack
2
2
Activation Failure
2
2
Firing Problem
2
2
Noise, Audible
1
1
Failure to Eject
1
1
Insufficient Information
1
1
Difficult or Delayed Positioning
1
1
Material Disintegration
1
1
Component Falling
1
1
Difficult to Insert
1
1
Loose or Intermittent Connection
1
1
Device Slipped
1
1
Misassembled
1
1
Bent
1
1
Device Contaminated During Manufacture or Shipping
1
1
Component Missing
1
1
Failure to Align
1
1
Malposition of Device
1
1
Device Operates Differently Than Expected
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
78
78
No Known Impact Or Consequence To Patient
60
60
No Clinical Signs, Symptoms or Conditions
60
60
Foreign Body In Patient
44
44
No Information
43
43
No Code Available
35
35
Unspecified Infection
19
19
Device Embedded In Tissue or Plaque
18
18
Non-union Bone Fracture
15
15
Pain
11
11
No Patient Involvement
6
6
Failure of Implant
5
5
Injury
4
4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Sleep Dysfunction
2
2
Ossification
2
2
Loss of Range of Motion
2
2
Difficulty Chewing
2
2
Impaired Healing
2
2
Reaction
1
1
Tooth Fracture
1
1
Post Operative Wound Infection
1
1
Limited Mobility Of The Implanted Joint
1
1
Decreased Sensitivity
1
1
Fluid Discharge
1
1
Increased Sensitivity
1
1
Tissue Damage
1
1
Fatigue
1
1
Bone Fracture(s)
1
1
Host-Tissue Reaction
1
1
Sedation
1
1
Physical Asymmetry
1
1
Swelling/ Edema
1
1
Insufficient Information
1
1
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