TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	278	278
Detachment of Device or Device Component	198	198
Separation Failure	185	185
Mechanical Problem	75	75
Adverse Event Without Identified Device or Use Problem	68	68
Use of Device Problem	30	30
Malposition of Device	30	30
Break	26	26
Material Deformation	24	24
Device Damaged by Another Device	21	21
Positioning Failure	18	18
Osseointegration Problem	12	12
Failure to Osseointegrate	11	11
Leak/Splash	11	11
Defective Device	10	10
Device Contamination with Chemical or Other Material	9	9
Positioning Problem	7	7
Separation Problem	6	6
Connection Problem	5	5
Unexpected Therapeutic Results	5	5
Loss of Osseointegration	4	4
Device Markings/Labelling Problem	4	4
No Apparent Adverse Event	4	4
Product Quality Problem	4	4
Insufficient Information	3	3
Appropriate Term/Code Not Available	3	3
Inadequacy of Device Shape and/or Size	3	3
Difficult to Insert	3	3
Component Missing	3	3
Improper or Incorrect Procedure or Method	2	2
Premature Separation	2	2
Inaccurate Information	2	2
Component or Accessory Incompatibility	2	2
Installation-Related Problem	2	2
Tear, Rip or Hole in Device Packaging	2	2
Labelling, Instructions for Use or Training Problem	2	2
Difficult or Delayed Separation	2	2
Device Handling Problem	2	2
Device-Device Incompatibility	2	2
Migration or Expulsion of Device	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Patient-Device Incompatibility	2	2
Output Problem	2	2
Complete Blockage	2	2
Failure to Eject	2	2
Compatibility Problem	1	1
Structural Problem	1	1
Failure to Cut	1	1
Activation, Positioning or Separation Problem	1	1
Lack of Effect	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	583	586
Failure of Implant	196	196
No Information	117	117
Insufficient Information	54	54
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	25	25
No Consequences Or Impact To Patient	16	16
Injury	14	14
Foreign Body In Patient	14	14
Perforation	13	13
Hemorrhage/Bleeding	10	10
Bacterial Infection	10	10
Laceration(s)	9	9
No Known Impact Or Consequence To Patient	9	9
Hematoma	8	8
Unspecified Infection	7	7
Pain	7	7
Osteopenia/ Osteoporosis	7	7
Thrombosis/Thrombus	7	7
Air Embolism	5	5
Inflammation	5	5
No Patient Involvement	5	5
Physical Asymmetry	4	4
Swelling/ Edema	4	4
Aspiration/Inhalation	4	4
Sinus Perforation	4	4
Discomfort	4	4
Abscess	3	3
Pseudoaneurysm	2	2
Unspecified Tissue Injury	2	2
Osteolysis	2	2
Granuloma	2	2
Sepsis	2	2
No Code Available	2	2
Bruise/Contusion	2	2
Erosion	1	1
Fibrosis	1	1
Headache	1	1
Sore Throat	1	1
Tissue Breakdown	1	1
Pocket Erosion	1	1
Device Embedded In Tissue or Plaque	1	1
Incompetent Cervix	1	1
Distress	1	1
Organ Dehiscence	1	1
Numbness	1	1
Nerve Damage	1	1
Burning Sensation	1	1
Paresthesia	1	1
Taste Disorder	1	1
Implant Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Implant Direct Sybron Manufacturing, LLC	II	Jan-08-2020
2	Nobel Biocare Usa Llc	II	Feb-19-2020
3	Paltop Advanced Dental Solutions Ltd	II	Oct-04-2021
4	Preat Corp	II	Aug-19-2024
5	Straumann USA LLC	II	Aug-03-2021
6	Thommen Medical AG	II	Mar-20-2024