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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 270 270
Separation Failure 219 219
Detachment of Device or Device Component 176 176
Adverse Event Without Identified Device or Use Problem 93 93
Mechanical Problem 79 79
Break 31 31
Malposition of Device 26 26
Use of Device Problem 25 25
Material Deformation 25 25
Positioning Failure 19 19
Device Damaged by Another Device 18 18
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
Material Integrity Problem 5 5
Unexpected Therapeutic Results 5 5
Connection Problem 5 5
Activation, Positioning or Separation Problem 4 4
Loss of Osseointegration 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
Inadequacy of Device Shape and/or Size 3 3
Accessory Incompatible 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
Unintended Movement 2 2
Device Handling Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Inaccurate Information 2 2
Output Problem 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Compatibility Problem 2 2
Installation-Related Problem 2 2
Free or Unrestricted Flow 1 1
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
No Pressure 1 1
Material Protrusion/Extrusion 1 1
Measurement System Incompatibility 1 1
Missing Information 1 1
Component Misassembled 1 1
Device Fell 1 1
Premature Separation 1 1
Patient Device Interaction Problem 1 1
Therapeutic or Diagnostic Output Failure 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
Failure to Disconnect 1 1
Fitting Problem 1 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 405 408
No Information 286 286
Failure of Implant 216 216
Insufficient Information 49 49
No Consequences Or Impact To Patient 48 48
Injury 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 23 23
No Code Available 20 20
No Known Impact Or Consequence To Patient 16 16
Perforation 16 16
Foreign Body In Patient 14 14
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 May-22-2019
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