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	411	411
Separation Failure	267	267
Detachment of Device or Device Component	255	255
Mechanical Problem	95	99
Adverse Event Without Identified Device or Use Problem	94	94
Use of Device Problem	51	51
Break	38	38
Malposition of Device	33	33
Device Damaged by Another Device	31	31
Material Deformation	30	30
Positioning Failure	24	24
Defective Device	17	17
Osseointegration Problem	14	14
Failure to Osseointegrate	13	13
Leak/Splash	11	11
Positioning Problem	10	10
Device Contamination with Chemical or Other Material	9	9
Separation Problem	8	8
Connection Problem	8	10
Loss of Osseointegration	6	6
Insufficient Information	6	6
No Apparent Adverse Event	5	5
Unexpected Therapeutic Results	5	5
Material Integrity Problem	5	5
Device Markings/Labelling Problem	5	5
Failure to Eject	5	5
Defective Component	4	4
Patient-Device Incompatibility	4	4
Appropriate Term/Code Not Available	4	4
Product Quality Problem	4	4
Inadequacy of Device Shape and/or Size	4	4
Activation, Positioning or Separation Problem	4	4
Unintended Movement	3	3
Manufacturing, Packaging or Shipping Problem	3	4
Improper or Incorrect Procedure or Method	3	3
Difficult to Insert	3	3
Accessory Incompatible	3	3
Component Missing	3	3
Compatibility Problem	3	3
Device-Device Incompatibility	3	3
Installation-Related Problem	3	3
Complete Blockage	2	2
Premature Separation	2	2
Inaccurate Information	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Structural Problem	2	2
Output Problem	2	2
Migration or Expulsion of Device	2	2
Device Handling Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	704	707
No Information	286	286
Failure of Implant	258	258
Insufficient Information	61	67
No Consequences Or Impact To Patient	48	48
Injury	29	29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	26	26
No Code Available	20	20
Perforation	16	16
No Known Impact Or Consequence To Patient	16	16
Foreign Body In Patient	15	15
Pain	11	11
No Patient Involvement	11	11
Bacterial Infection	10	10
Hemorrhage/Bleeding	10	10
Laceration(s)	9	9
Unspecified Infection	8	8
Hematoma	8	8
Osteopenia/ Osteoporosis	8	8
Thrombosis/Thrombus	7	7
Swelling/ Edema	5	5
Discomfort	5	5
Sinus Perforation	5	5
Inflammation	5	5
Air Embolism	5	5
Aspiration/Inhalation	4	4
Osteolysis	4	4
Physical Asymmetry	4	4
Abscess	3	3
Granuloma	2	2
Sepsis	2	2
Bruise/Contusion	2	2
Device Embedded In Tissue or Plaque	2	2
Unspecified Tissue Injury	2	2
Pseudoaneurysm	2	2
Headache	1	1
Erosion	1	1
Sore Throat	1	1
Fibrosis	1	1
Pocket Erosion	1	1
Tissue Breakdown	1	1
Organ Dehiscence	1	1
Incompetent Cervix	1	1
Distress	1	1
Perforation of Vessels	1	1
Numbness	1	1
Nerve Damage	1	1
Burning Sensation	1	1
Paresthesia	1	1
Implant Pain	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	Implant Direct Sybron Manufacturing, LLC	II	Oct-31-2019
4	Nobel Biocare Usa Llc	II	Feb-19-2020
5	Paltop Advanced Dental Solutions Ltd	II	Oct-04-2021
6	Preat Corp	II	Aug-19-2024
7	Prismatik Dentalcraft, Inc.	II	May-28-2025
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	Thommen Medical AG	II	May-22-2019
12	TruAbutment Inc.	II	Mar-11-2025