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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 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 273 273
Separation Failure 225 225
Detachment of Device or Device Component 190 190
Adverse Event Without Identified Device or Use Problem 93 93
Mechanical Problem 79 79
Break 31 31
Malposition of Device 27 27
Use of Device Problem 26 26
Material Deformation 25 25
Positioning Failure 20 20
Device Damaged by Another Device 19 19
Defective Device 15 15
Osseointegration Problem 12 12
Failure to Osseointegrate 11 11
Leak/Splash 11 11
Positioning Problem 10 10
Device Contamination with Chemical or Other Material 9 9
Separation Problem 8 8
Device Markings/Labelling Problem 5 5
Material Integrity Problem 5 5
Unexpected Therapeutic Results 5 5
No Apparent Adverse Event 5 5
Connection Problem 5 5
Activation, Positioning or Separation Problem 4 4
Appropriate Term/Code Not Available 4 4
Defective Component 4 4
Product Quality Problem 4 4
Insufficient Information 4 4
Loss of Osseointegration 4 4
Inadequacy of Device Shape and/or Size 3 3
Device-Device Incompatibility 3 3
Accessory Incompatible 3 3
Manufacturing, Packaging or Shipping Problem 3 4
Component Missing 3 3
Difficult or Delayed Separation 2 2
Compatibility Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Unstable 2 2
Tear, Rip or Hole in Device Packaging 2 2
Migration or Expulsion of Device 2 2
Patient-Device Incompatibility 2 2
Labelling, Instructions for Use or Training Problem 2 2
Output Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Unintended Movement 2 2
Device Handling Problem 2 2
Complete Blockage 2 2
Inaccurate Information 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Component or Accessory Incompatibility 2 2
Installation-Related Problem 2 2
Patient Device Interaction Problem 1 1
Material Protrusion/Extrusion 1 1
Unsealed Device Packaging 1 1
Material Separation 1 1
Fitting Problem 1 3
No Pressure 1 1
Crack 1 1
Entrapment of Device 1 1
Failure to Disconnect 1 1
Difficult to Insert 1 1
Premature Separation 1 1
Free or Unrestricted Flow 1 1
Loose or Intermittent Connection 1 1
Measurement System Incompatibility 1 1
Difficult to Remove 1 1
Device Fell 1 1
Missing Information 1 1
Corroded 1 1
Failure to Eject 1 1
Device Dislodged or Dislocated 1 1
Therapeutic or Diagnostic Output Failure 1 1
Lack of Effect 1 1
Component Misassembled 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 429 432
No Information 286 286
Failure of Implant 220 220
Insufficient Information 49 49
No Consequences Or Impact To Patient 48 48
Injury 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
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
Hematoma 8 8
Unspecified Infection 8 8
Laceration(s) 8 8
Osteopenia/ Osteoporosis 8 8
Thrombosis/Thrombus 7 7
Pain 6 6
Air Embolism 5 5
Inflammation 4 4
Sinus Perforation 4 4
Discomfort 4 4
Physical Asymmetry 4 4
Swelling/ Edema 3 3
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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