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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessories, implant, dental, endosseous
Product CodeNDP
Regulation Number 872.3980
Device Class 1


Premarket Reviews
ManufacturerDecision
DENTSPLY SIRONA
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 262 262
2020 183 183
2021 237 237
2022 189 192
2023 211 211
2024 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 291 291
Separation Failure 232 232
Detachment of Device or Device Component 205 205
Adverse Event Without Identified Device or Use Problem 94 94
Mechanical Problem 80 80
Break 32 32
Use of Device Problem 30 30
Malposition of Device 29 29
Material Deformation 26 26
Device Damaged by Another Device 20 20
Positioning Failure 20 20
Defective Device 16 16
Osseointegration Problem 12 12
Leak/Splash 11 11
Failure to Osseointegrate 11 11
Positioning Problem 10 10
Device Contamination with Chemical or Other Material 9 9
Separation Problem 8 8
No Apparent Adverse Event 5 5
Device Markings/Labelling Problem 5 5
Material Integrity Problem 5 5
Unexpected Therapeutic Results 5 5
Connection Problem 5 5
Loss of Osseointegration 5 5
Activation, Positioning or Separation Problem 4 4
Defective Component 4 4
Product Quality Problem 4 4
Insufficient Information 4 4
Appropriate Term/Code Not Available 4 4
Manufacturing, Packaging or Shipping Problem 3 4
Device-Device Incompatibility 3 3
Accessory Incompatible 3 3
Inadequacy of Device Shape and/or Size 3 3
Component Missing 3 3
Tear, Rip or Hole in Device Packaging 2 2
Unstable 2 2
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 2 2
Component or Accessory Incompatibility 2 2
Migration or Expulsion of Device 2 2
Difficult to Insert 2 2
Labelling, Instructions for Use or Training Problem 2 2
Complete Blockage 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Compatibility Problem 2 2
Installation-Related Problem 2 2
Device Handling Problem 2 2
Output Problem 2 2
Difficult or Delayed Separation 2 2
Premature Separation 2 2
Inaccurate Information 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Unintended Movement 2 2
Component Misassembled 1 1
Failure to Eject 1 1
Device Fell 1 1
Missing Information 1 1
Lack of Effect 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Free or Unrestricted Flow 1 1
Device Dislodged or Dislocated 1 1
No Pressure 1 1
Material Protrusion/Extrusion 1 1
Measurement System Incompatibility 1 1
Corroded 1 1
Crack 1 1
Entrapment of Device 1 1
Unsealed Device Packaging 1 1
Loose or Intermittent Connection 1 1
Difficult to Remove 1 1
Material Separation 1 1
Failure to Disconnect 1 1
Failure to Cut 1 1
Fitting Problem 1 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 471 474
No Information 286 286
Failure of Implant 223 223
Insufficient Information 54 54
No Consequences Or Impact To Patient 48 48
Injury 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 25 25
No Code Available 20 20
No Known Impact Or Consequence To Patient 16 16
Perforation 16 16
Foreign Body In Patient 15 15
No Patient Involvement 11 11
Hemorrhage/Bleeding 10 10
Bacterial Infection 10 10
Laceration(s) 9 9
Unspecified Infection 8 8
Hematoma 8 8
Osteopenia/ Osteoporosis 8 8
Pain 8 8
Thrombosis/Thrombus 7 7
Sinus Perforation 5 5
Air Embolism 5 5
Inflammation 4 4
Discomfort 4 4
Physical Asymmetry 4 4
Swelling/ Edema 4 4
Osteolysis 3 3
Aspiration/Inhalation 3 3
Abscess 3 3
Granuloma 2 2
Bruise/Contusion 2 2
Sepsis 2 2
Pseudoaneurysm 2 2
Unspecified Tissue Injury 2 2
Device Embedded In Tissue or Plaque 2 2
Fibrosis 1 1
Vascular Dissection 1 1
Implant Pain 1 1
Paresthesia 1 1
Pocket Erosion 1 1
Ischemic Heart Disease 1 1
Organ Dehiscence 1 1
Inadequate Osseointegration 1 1
Tissue Breakdown 1 1
Patient Problem/Medical Problem 1 1
Bone Fracture(s) 1 1
Erosion 1 1
Nerve Damage 1 1
Incompetent Cervix 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 Nobel Biocare Usa Llc II Feb-19-2020
4 Paltop Advanced Dental Solutions Ltd II Oct-04-2021
5 Straumann USA LLC II Aug-03-2021
6 Thommen Medical AG II Mar-20-2024
7 Thommen Medical AG II May-22-2019
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