TPLC - Total Product Life Cycle

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Device	accessories, implant, dental, endosseous
Regulation Description	Endosseous dental implant accessories.
Product Code	NDP
Regulation Number	872.3980
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	1581	1583
Mechanical Problem	269	276
Detachment of Device or Device Component	231	232
Separation Failure	187	189
Adverse Event Without Identified Device or Use Problem	50	51
Use of Device Problem	43	43
Material Deformation	42	42
Malposition of Device	30	30
Device Damaged by Another Device	29	32
Insufficient Information	23	23
Positioning Failure	23	24
Break	18	20
Loose or Intermittent Connection	16	16
Failure to Osseointegrate	13	13
Osseointegration Problem	13	13
Mechanical Jam	13	13
Defective Device	10	10
Connection Problem	7	21
Separation Problem	7	7
Material Twisted/Bent	6	6
Loss of Osseointegration	6	6
Leak/Splash	6	6
Inadequacy of Device Shape and/or Size	5	5
Failure to Eject	5	5
Device-Device Incompatibility	4	4
Device Contamination with Chemical or Other Material	4	4
Unexpected Therapeutic Results	4	4
Off-Label Use	4	4
Product Quality Problem	4	4
Patient-Device Incompatibility	4	4
Fitting Problem	3	16
Difficult to Insert	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Installation-Related Problem	3	3
No Apparent Adverse Event	3	15
Appropriate Term/Code Not Available	3	3
Device Handling Problem	3	3
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Output Problem	2	2
Unintended Movement	2	3
Labelling, Instructions for Use or Training Problem	2	2
Migration or Expulsion of Device	2	2
Misconnection	2	25
Tear, Rip or Hole in Device Packaging	2	2
Dull, Blunt	2	2
Component or Accessory Incompatibility	2	2
Structural Problem	2	2
Difficult or Delayed Separation	2	2
Premature Separation	1	1
Lack of Effect	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2267	2281
Failure of Implant	219	222
Insufficient Information	74	103
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	36	36
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
Sinus Perforation	5	5
Osteopenia/ Osteoporosis	5	5
Physical Asymmetry	4	4
Discomfort	4	4
Inflammation	4	4
Aspiration/Inhalation	4	4
Unspecified Infection	4	4
Osteolysis	3	3
Abscess	3	3
Implant Pain	2	2
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
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
Deformity/ Disfigurement	1	1
Sore Throat	1	1
Fibrosis	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	III	Feb-09-2026
6	Straumann USA LLC	II	Apr-14-2025
7	Straumann USA LLC	II	Aug-03-2021
8	Thommen Medical AG	II	Mar-20-2024
9	TruAbutment Inc.	II	Mar-11-2025