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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
Regulation Description Endosseous dental implant accessories.
Product CodeNDP
Regulation Number 872.3980
Device Class 1

MDR Year MDR Reports MDR Events
2021 237 237
2022 188 196
2023 212 220
2024 224 225
2025 390 396

Device Problems MDRs with this Device Problem Events in those MDRs
Fracture 484 486
Detachment of Device or Device Component 219 220
Separation Failure 172 174
Mechanical Problem 79 86
Adverse Event Without Identified Device or Use Problem 50 51
Use of Device Problem 41 41
Device Damaged by Another Device 28 31
Malposition of Device 28 28
Material Deformation 26 26
Positioning Failure 21 22
Break 18 20
Osseointegration Problem 13 13
Failure to Osseointegrate 10 10
Defective Device 10 10
Connection Problem 6 8
Leak/Splash 6 6
Separation Problem 6 6
Loss of Osseointegration 5 5
Failure to Eject 5 5
Patient-Device Incompatibility 4 4
Insufficient Information 4 4
Unexpected Therapeutic Results 4 4
Device Contamination with Chemical or Other Material 4 4
Product Quality Problem 4 4
Inadequacy of Device Shape and/or Size 4 4
Loose or Intermittent Connection 3 3
Appropriate Term/Code Not Available 3 3
Difficult to Insert 3 3
Installation-Related Problem 3 3
Unintended Movement 2 3
Output Problem 2 2
Fitting Problem 2 4
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Component or Accessory Incompatibility 2 2
Off-Label Use 2 2
Migration or Expulsion of Device 2 2
Structural Problem 2 2
Device-Device Incompatibility 2 2
Device Handling Problem 2 2
Difficult or Delayed Separation 2 2
Labelling, Instructions for Use or Training Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Mechanical Jam 1 1
Failure to Disconnect 1 1
Improper or Incorrect Procedure or Method 1 1
Premature Separation 1 1
Nonstandard Device 1 1
Device Dislodged or Dislocated 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 923 937
Failure of Implant 188 191
Insufficient Information 59 65
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
No Information 14 14
Perforation 11 11
Hemorrhage/Bleeding 10 10
Bacterial Infection 10 10
Foreign Body In Patient 10 10
Pain 9 9
Laceration(s) 9 9
Hematoma 8 8
Thrombosis/Thrombus 7 7
Air Embolism 5 5
Swelling/ Edema 5 5
Osteopenia/ Osteoporosis 5 5
Physical Asymmetry 4 4
Discomfort 4 4
Sinus Perforation 4 4
Inflammation 4 4
Aspiration/Inhalation 4 4
Unspecified Infection 4 4
Osteolysis 3 3
Abscess 3 3
Sepsis 2 2
Unspecified Tissue Injury 2 2
Pseudoaneurysm 2 2
Granuloma 2 2
Bruise/Contusion 2 2
Ischemic Heart Disease 1 1
Taste Disorder 1 1
Implant Pain 1 1
Bone Fracture(s) 1 1
No Known Impact Or Consequence To Patient 1 1
Paresthesia 1 1
Burning Sensation 1 1
Inadequate Osseointegration 1 1
Nerve Damage 1 1
Numbness 1 1
Dry Mouth 1 1
Speech Disorder 1 1
Perforation of Vessels 1 1
Hypersensitivity/Allergic reaction 1 1
Organ Dehiscence 1 1
Weight Changes 1 1
Erosion 1 1
Headache 1 1
Sore Throat 1 1
Fibrosis 1 1
Pocket Erosion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dentsply IH, Inc. II Aug-25-2025
2 Paltop Advanced Dental Solutions Ltd II Oct-04-2021
3 Preat Corp II Aug-19-2024
4 Prismatik Dentalcraft, Inc. II May-28-2025
5 Straumann USA LLC II Apr-14-2025
6 Straumann USA LLC II Aug-03-2021
7 Thommen Medical AG II Mar-20-2024
8 TruAbutment Inc. II Mar-11-2025
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