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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
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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