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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 69 69

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 280 280
Separation Failure 226 226
Detachment of Device or Device Component 196 196
Adverse Event Without Identified Device or Use Problem 93 93
Mechanical Problem 80 80
Break 31 31
Malposition of Device 29 29
Use of Device Problem 28 28
Material Deformation 26 26
Device Damaged by Another Device 20 20
Positioning Failure 20 20
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
No Apparent Adverse Event 5 5
Device Markings/Labelling Problem 5 5
Connection Problem 5 5
Material Integrity Problem 5 5
Unexpected Therapeutic Results 5 5
Defective Component 4 4
Loss of Osseointegration 4 4
Product Quality Problem 4 4
Activation, Positioning or Separation 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
Labelling, Instructions for Use or Training Problem 2 2
Migration or Expulsion of Device 2 2
Complete Blockage 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Compatibility Problem 2 2
Installation-Related Problem 2 2
Unintended Movement 2 2
Difficult or Delayed Separation 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Device Handling Problem 2 2
Output Problem 2 2
Inaccurate Information 2 2
Missing Information 1 1
Lack of Effect 1 1
Therapeutic or Diagnostic Output Failure 1 1
Patient Device Interaction Problem 1 1
Component Misassembled 1 1
Failure to Eject 1 1
Device Fell 1 1
Premature Separation 1 1
No Pressure 1 1
Material Protrusion/Extrusion 1 1
Measurement System Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Free or Unrestricted Flow 1 1
Corroded 1 1
Crack 1 1
Entrapment of Device 1 1
Difficult to Insert 1 1
Unsealed Device Packaging 1 1
Difficult to Remove 1 1
Material Separation 1 1
Loose or Intermittent Connection 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 446 449
No Information 286 286
Failure of Implant 222 222
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
Pain 7 7
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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