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TPLC
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Device
accessories, implant, dental, endosseous
Product Code
NDP
Regulation Number
872.3980
Device Class
1
Premarket Reviews
Manufacturer
Decision
DENTSPLY SIRONA
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
279
279
2019
262
262
2020
183
183
2021
237
237
2022
193
196
2023
73
73
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
317
317
Separation Failure
245
245
Detachment of Device or Device Component
144
144
Adverse Event Without Identified Device or Use Problem
125
125
Mechanical Problem
96
96
Break
41
41
Malposition of Device
26
26
Use of Device Problem
25
25
Material Deformation
20
20
Device Damaged by Another Device
19
19
Positioning Failure
12
12
Leak/Splash
12
12
Defective Device
11
11
Osseointegration Problem
11
11
Positioning Problem
10
10
Separation Problem
10
10
Device Contamination with Chemical or Other Material
9
9
Failure to Osseointegrate
8
8
Appropriate Term/Code Not Available
7
7
Device-Device Incompatibility
6
6
Device Markings/Labelling Problem
6
6
Defective Component
6
6
Premature Separation
6
6
Inaccurate Information
6
6
Component Missing
5
5
Unexpected Therapeutic Results
5
5
Connection Problem
5
5
Manufacturing, Packaging or Shipping Problem
5
6
No Apparent Adverse Event
5
5
Material Integrity Problem
5
5
Insufficient Information
4
4
Component Misassembled
4
4
Activation, Positioning or Separation Problem
4
4
Accessory Incompatible
4
4
Detachment Of Device Component
4
4
Migration or Expulsion of Device
3
3
Improper or Incorrect Procedure or Method
3
3
Inadequacy of Device Shape and/or Size
3
3
Loss of Osseointegration
3
3
Patient-Device Incompatibility
3
3
Device Operates Differently Than Expected
3
3
Compatibility Problem
2
2
Installation-Related Problem
2
2
Tear, Rip or Hole in Device Packaging
2
2
Component or Accessory Incompatibility
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Unintended Movement
2
2
Output Problem
2
2
Unstable
2
2
Fitting Problem
2
4
Product Quality Problem
2
2
Nonstandard Device
2
2
Complete Blockage
2
2
Material Fragmentation
2
2
Difficult to Insert
1
1
Labelling, Instructions for Use or Training Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Corroded
1
1
Unsealed Device Packaging
1
1
Device Difficult to Setup or Prepare
1
1
Entrapment of Device
1
1
Difficult to Remove
1
1
Material Separation
1
1
Device Inoperable
1
1
Incomplete or Missing Packaging
1
1
Failure to Align
1
1
No Pressure
1
1
Material Protrusion/Extrusion
1
1
Mechanics Altered
1
1
Material Split, Cut or Torn
1
1
Device Fell
1
1
Device Handling Problem
1
1
Patient Device Interaction Problem
1
1
Deformation Due to Compressive Stress
1
1
Device Dislodged or Dislocated
1
1
Free or Unrestricted Flow
1
1
Missing Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Information
472
472
No Clinical Signs, Symptoms or Conditions
298
301
Failure of Implant
202
202
No Consequences Or Impact To Patient
71
71
No Code Available
56
56
Insufficient Information
48
48
Injury
34
34
Perforation
27
27
No Known Impact Or Consequence To Patient
21
21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
17
17
No Patient Involvement
16
16
Foreign Body In Patient
13
13
Hemorrhage/Bleeding
10
10
Bacterial Infection
10
10
Unspecified Infection
9
9
Hematoma
8
8
Thrombosis/Thrombus
7
7
Osteopenia/ Osteoporosis
6
6
Air Embolism
5
5
Discomfort
4
4
Laceration(s)
4
4
Pain
4
4
Physical Asymmetry
4
4
Swelling/ Edema
3
3
Device Embedded In Tissue or Plaque
3
3
Nerve Damage
3
3
Osteolysis
3
3
Numbness
3
3
Aspiration/Inhalation
3
3
Abscess
3
3
Inflammation
3
3
Bone Fracture(s)
2
2
Granuloma
2
2
Bruise/Contusion
2
2
Pseudoaneurysm
2
2
Sepsis
2
2
Sinus Perforation
2
2
Pocket Erosion
1
1
Inadequate Osseointegration
1
1
Ischemic Heart Disease
1
1
Organ Dehiscence
1
1
Edema
1
1
Erosion
1
1
Wound Dehiscence
1
1
Incompetent Cervix
1
1
Fibrosis
1
1
Vascular Dissection
1
1
Tissue Breakdown
1
1
Patient Problem/Medical Problem
1
1
Unspecified Tissue Injury
1
1
Paresthesia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Implant Direct Sybron Manufacturing, LLC
II
Jan-08-2020
2
Implant Direct Sybron Manufacturing, LLC
II
Oct-31-2019
3
Implant Direct Sybron Manufacturing, LLC
II
Oct-09-2018
4
Keystone Dental Inc
II
Apr-19-2018
5
Nobel Biocare Usa Llc
II
Feb-19-2020
6
Paltop Advanced Dental Solutions Ltd
II
Oct-04-2021
7
Straumann USA LLC
II
Aug-03-2021
8
Thommen Medical AG
II
May-22-2019
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