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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 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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