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	2179	2181
Mechanical Problem	391	398
Detachment of Device or Device Component	246	247
Separation Failure	233	235
Adverse Event Without Identified Device or Use Problem	67	68
Use of Device Problem	47	47
Material Deformation	47	47
Mechanical Jam	35	35
Malposition of Device	32	32
Device Damaged by Another Device	30	33
Insufficient Device Problem Information	26	26
Positioning Failure	24	25
Loose or Intermittent Connection	18	18
Break	18	20
Failure to Osseointegrate	17	17
Osseointegration Problem	13	13
Leak/Splash	11	11
Defective Device	10	10
Connection Problem	10	24
Device Contamination with Chemical or Other Material	9	9
Separation Problem	8	8
Off-Label Use	7	7
No Apparent Adverse Event	7	19
Loss of Osseointegration	6	6
Material Twisted/Bent	6	6
Improper or Incorrect Procedure or Method	5	5
Unexpected Therapeutic Results	5	5
Failure to Eject	5	5
Positioning Problem	5	5
Difficult to Insert	4	4
Device-Device Incompatibility	4	4
Device Markings/Labelling Problem	4	4
Patient-Device Incompatibility	4	4
Appropriate Device Problem Term/Code Not Available	3	3
Device Handling Problem	3	3
Installation-Related Problem	3	3
Component Missing	3	3
Fitting Problem	3	16
Inadequacy of Device Shape and/or Size	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Migration or Expulsion of Device	2	2
Misconnection	2	25
Unintended Movement	2	3
Structural Problem	2	2
Dull, Blunt	2	2
Tear, Rip or Hole in Device Packaging	2	2
Compatibility Problem	2	2
Difficult or Delayed Separation	2	2
Premature Separation	2	2
Inaccurate Information	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2952	2966
Failure of Implant	269	272
No Information	117	117
Insufficient Information	77	106
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	41	41
No Consequences Or Impact To Patient	16	16
Injury	14	14
Foreign Body In Patient	14	14
Perforation	13	13
Bacterial Infection	10	10
Hemorrhage/Blood Loss/Bleeding	10	10
Laceration(s)	9	9
Pain	9	9
No Known Impact Or Consequence To Patient	9	9
Unspecified Infection	9	9
Hematoma	8	8
Thrombosis/Thrombus	7	7
Osteopenia/ Osteoporosis	7	7
No Patient Involvement	5	5
Swelling/ Edema	5	5
Inflammation	5	5
Air Embolism	5	5
Sinus Perforation	5	5
Aspiration/Inhalation	4	4
Discomfort	4	4
Osteolysis	4	4
Physical Asymmetry	4	4
Abscess	3	3
Sepsis	2	2
Pseudoaneurysm	2	2
No Code Available	2	2
Periprosthetic fracture	2	2
Unspecified Tissue Injury	2	2
Bruise/Contusion	2	2
Implant Pain	2	2
Granuloma	2	2
Inadequate Osseointegration	1	1
Speech Disorder	1	1
Ischemic Heart Disease	1	1
Numbness	1	1
Perforation of Vessels	1	1
Weight Changes	1	1
Bone Fracture(s)	1	1
Headache	1	1
Tissue Breakdown	1	1
Taste Disorder	1	1
Organ Dehiscence	1	1
Nerve Damage	1	1
Deformity/ Disfigurement	1	1
Hypersensitivity/Allergic reaction	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Dentsply IH, Inc.	II	Aug-25-2025
2	Implant Direct Sybron Manufacturing, LLC	II	Jan-08-2020
3	Nobel Biocare Usa Llc	II	Feb-19-2020
4	Paltop Advanced Dental Solutions Ltd	II	Oct-04-2021
5	Preat Corp	II	Aug-19-2024
6	Prismatik Dentalcraft, Inc.	II	May-28-2025
7	Straumann USA LLC	III	Feb-09-2026
8	Straumann USA LLC	II	Apr-14-2025
9	Straumann USA LLC	II	Aug-03-2021
10	Thommen Medical AG	II	Mar-20-2024
11	TruAbutment Inc.	II	Mar-11-2025