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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
190
193
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fracture
290
290
Separation Failure
231
231
Detachment of Device or Device Component
131
131
Adverse Event Without Identified Device or Use Problem
125
125
Mechanical Problem
89
89
Break
40
40
Malposition of Device
25
25
Use of Device Problem
22
22
Device Damaged by Another Device
17
17
Material Deformation
17
17
Leak/Splash
12
12
Osseointegration Problem
11
11
Positioning Failure
11
11
Defective Device
11
11
Positioning Problem
10
10
Separation Problem
9
9
Device Contamination with Chemical or Other Material
9
9
Failure to Osseointegrate
8
8
Appropriate Term/Code Not Available
7
7
Premature Separation
6
6
Device Markings/Labelling Problem
6
6
Inaccurate Information
6
6
Defective Component
6
6
Device-Device Incompatibility
6
6
Material Integrity Problem
5
5
Unexpected Therapeutic Results
5
5
Manufacturing, Packaging or Shipping Problem
5
6
Connection Problem
5
5
No Apparent Adverse Event
5
5
Component Missing
5
5
Insufficient Information
4
4
Activation, Positioning or Separation Problem
4
4
Component Misassembled
4
4
Accessory Incompatible
4
4
Detachment Of Device Component
4
4
Inadequacy of Device Shape and/or Size
3
3
Improper or Incorrect Procedure or Method
3
3
Loss of Osseointegration
3
3
Patient-Device Incompatibility
3
3
Device Operates Differently Than Expected
3
3
Migration or Expulsion of Device
3
3
Complete Blockage
2
2
Material Fragmentation
2
2
Installation-Related Problem
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Compatibility Problem
2
2
Fitting Problem
2
4
Tear, Rip or Hole in Device Packaging
2
2
Unstable
2
2
Product Quality Problem
2
2
Unintended Movement
2
2
Output Problem
2
2
Nonstandard Device
2
2
Device Difficult to Setup or Prepare
1
1
Inadequate Instructions for Healthcare Professional
1
1
Failure to Align
1
1
Deformation Due to Compressive Stress
1
1
Device Dislodged or Dislocated
1
1
Material Split, Cut or Torn
1
1
Entrapment of Device
1
1
Difficult to Insert
1
1
Mechanics Altered
1
1
Free or Unrestricted Flow
1
1
Device Fell
1
1
Missing Information
1
1
No Pressure
1
1
Corroded
1
1
Device Inoperable
1
1
Material Protrusion/Extrusion
1
1
Device Handling Problem
1
1
Patient Device Interaction Problem
1
1
Incomplete or Missing Packaging
1
1
Unsealed Device Packaging
1
1
Difficult to Remove
1
1
Material Separation
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Information
472
472
No Clinical Signs, Symptoms or Conditions
242
245
Failure of Implant
184
184
No Consequences Or Impact To Patient
71
71
No Code Available
56
56
Insufficient Information
45
45
Injury
34
34
Perforation
26
26
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
Bacterial Infection
10
10
Hemorrhage/Bleeding
10
10
Unspecified Infection
9
9
Hematoma
8
8
Thrombosis/Thrombus
7
7
Osteopenia/ Osteoporosis
6
6
Air Embolism
5
5
Physical Asymmetry
4
4
Laceration(s)
4
4
Pain
4
4
Device Embedded In Tissue or Plaque
3
3
Nerve Damage
3
3
Numbness
3
3
Abscess
3
3
Osteolysis
3
3
Inflammation
3
3
Aspiration/Inhalation
3
3
Swelling/ Edema
3
3
Bone Fracture(s)
2
2
Pseudoaneurysm
2
2
Bruise/Contusion
2
2
Sinus Perforation
2
2
Sepsis
2
2
Granuloma
2
2
Discomfort
2
2
Fibrosis
1
1
Pocket Erosion
1
1
Incompetent Cervix
1
1
Inadequate Osseointegration
1
1
Tissue Breakdown
1
1
Wound Dehiscence
1
1
Vascular Dissection
1
1
Paresthesia
1
1
Erosion
1
1
Ischemic Heart Disease
1
1
Organ Dehiscence
1
1
Edema
1
1
Patient Problem/Medical Problem
1
1
Unspecified Tissue Injury
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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