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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 3

MDR Year MDR Reports MDR Events
2017 240 240
2018 279 279
2019 262 262
2020 183 183
2021 237 237
2022 167 170

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 339 339
Separation Failure 280 280
Mechanical Problem 175 175
Adverse Event Without Identified Device or Use Problem 148 148
Detachment of Device or Device Component 126 126
Break 44 44
Malposition of Device 26 26
Use of Device Problem 22 22
Positioning Failure 19 19
Device Damaged by Another Device 18 18
Material Deformation 18 18
Appropriate Term/Code Not Available 16 16
Osseointegration Problem 12 12
Defective Device 12 12
Positioning Problem 11 11
Leak/Splash 10 10
Manufacturing, Packaging or Shipping Problem 9 10
Device-Device Incompatibility 9 9
Device Contamination with Chemical or Other Material 9 9
Separation Problem 9 9
Failure to Osseointegrate 8 8
Detachment Of Device Component 7 7
Defective Component 6 6
Device Markings/Labelling Problem 6 6
Material Integrity Problem 6 6
Premature Separation 6 6
Inaccurate Information 6 6
No Apparent Adverse Event 5 5
Insufficient Information 5 5
Connection Problem 5 5
Component Missing 5 5
Unexpected Therapeutic Results 5 5
Improper or Incorrect Procedure or Method 4 4
Accessory Incompatible 4 4
Material Fragmentation 4 4
Activation, Positioning or Separation Problem 4 4
Device Operates Differently Than Expected 4 4
Device Handling Problem 4 4
Component Misassembled 4 4
Patient-Device Incompatibility 3 3
Compatibility Problem 3 3
Migration or Expulsion of Device 3 3
Nonstandard Device 3 3
Inadequacy of Device Shape and/or Size 3 3
Loss of Osseointegration 3 3
Product Quality Problem 2 2
Fitting Problem 2 4
Complete Blockage 2 2
Installation-Related Problem 2 2
Human Factors Issue 2 2
Unintended Movement 2 2
Output Problem 2 2
Unstable 2 2
Tear, Rip or Hole in Device Packaging 2 2
Component or Accessory Incompatibility 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Free or Unrestricted Flow 1 1
Device Dislodged or Dislocated 1 1
Deformation Due to Compressive Stress 1 1
Physical Property Issue 1 1
No Pressure 1 1
Material Protrusion/Extrusion 1 1
Mechanics Altered 1 1
Corroded 1 1
Difficult to Insert 1 1
Inadequate Instructions for Healthcare Professional 1 1
Unsealed Device Packaging 1 1
Device Difficult to Setup or Prepare 1 1
Loose or Intermittent Connection 1 1
Entrapment of Device 1 1
Difficult to Remove 1 1
Material Separation 1 1
Structural Problem 1 1
Failure to Align 1 1
Failure to Advance 1 1
Device Inoperable 1 1
Incomplete or Missing Packaging 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1
Patient Device Interaction Problem 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 644 644
No Clinical Signs, Symptoms or Conditions 220 223
Failure of Implant 184 184
No Code Available 93 93
No Consequences Or Impact To Patient 75 75
Insufficient Information 45 45
Perforation 39 39
Injury 36 36
No Known Impact Or Consequence To Patient 28 28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
No Patient Involvement 16 16
Foreign Body In Patient 15 15
Hemorrhage/Bleeding 10 10
Bacterial Infection 10 10
Unspecified Infection 9 9
Hematoma 8 8
Thrombosis/Thrombus 7 7
Osteopenia/ Osteoporosis 6 6
Device Embedded In Tissue or Plaque 5 5
Air Embolism 5 5
Pain 5 5
Numbness 5 5
Laceration(s) 4 4
Physical Asymmetry 4 4
Swelling/ Edema 3 3
Nerve Damage 3 3
Sinus Perforation 3 3
Osteolysis 3 3
Aspiration/Inhalation 3 3
Abscess 3 3
Bone Fracture(s) 3 3
Inflammation 3 3
Granuloma 2 2
Edema 2 2
Bruise/Contusion 2 2
Impaired Healing 2 2
Sepsis 2 2
Pseudoaneurysm 2 2
Discomfort 2 2
Pocket Erosion 1 1
Inadequate Osseointegration 1 1
Ischemic Heart Disease 1 1
Organ Dehiscence 1 1
Debris, Bone Shedding 1 1
Erosion 1 1
Wound Dehiscence 1 1
Incompetent Cervix 1 1
Unspecified Tissue Injury 1 1
Paresthesia 1 1
Fibrosis 1 1
Vascular Dissection 1 1
Tissue Breakdown 1 1
Patient Problem/Medical Problem 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 Implant Direct Sybron Manufacturing, LLC II Dec-21-2017
5 Instradent USA, Inc. II Apr-07-2017
6 Keystone Dental Inc II Apr-19-2018
7 Nobel Biocare Usa Llc II Feb-19-2020
8 Paltop Advanced Dental Solutions Ltd II Oct-04-2021
9 Straumann Manufacturing, Inc. II Jan-06-2017
10 Straumann USA LLC II Aug-03-2021
11 Thommen Medical AG II May-22-2019
12 Zimmer Dental Inc II Dec-21-2017
13 Zimmer Dental Inc II Sep-22-2017
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