TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	2

MDR Year	MDR Reports	MDR Events
2019	262	262
2020	183	183
2021	237	237
2022	189	192
2023	211	211
2024	136	136

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	298	298
Separation Failure	238	238
Detachment of Device or Device Component	213	213
Adverse Event Without Identified Device or Use Problem	94	94
Mechanical Problem	81	81
Use of Device Problem	35	35
Break	34	34
Malposition of Device	29	29
Material Deformation	28	28
Device Damaged by Another Device	22	22
Positioning Failure	20	20
Defective Device	16	16
Osseointegration Problem	12	12
Failure to Osseointegrate	12	12
Leak/Splash	11	11
Positioning Problem	10	10
Device Contamination with Chemical or Other Material	9	9
Separation Problem	8	8
Loss of Osseointegration	5	5
Unexpected Therapeutic Results	5	5
Connection Problem	5	5
Material Integrity Problem	5	5
Device Markings/Labelling Problem	5	5
No Apparent Adverse Event	5	5
Appropriate Term/Code Not Available	4	4
Defective Component	4	4
Insufficient Information	4	4
Product Quality Problem	4	4
Activation, Positioning or Separation Problem	4	4
Inadequacy of Device Shape and/or Size	3	3
Device-Device Incompatibility	3	3
Manufacturing, Packaging or Shipping Problem	3	4
Accessory Incompatible	3	3
Component Missing	3	3
Improper or Incorrect Procedure or Method	2	2
Device Handling Problem	2	2
Difficult or Delayed Separation	2	2
Premature Separation	2	2
Inaccurate Information	2	2
Component or Accessory Incompatibility	2	2
Unstable	2	2
Compatibility Problem	2	2
Loosening of Implant Not Related to Bone-Ingrowth	2	2
Difficult to Insert	2	2
Complete Blockage	2	2
Patient-Device Incompatibility	2	2
Unintended Movement	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Output Problem	2	2
Migration or Expulsion of Device	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	500	503
No Information	286	286
Failure of Implant	226	226
Insufficient Information	54	54
No Consequences Or Impact To Patient	48	48
Injury	29	29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	25	25
No Code Available	20	20
Perforation	16	16
No Known Impact Or Consequence To Patient	16	16
Foreign Body In Patient	15	15
No Patient Involvement	11	11
Hemorrhage/Bleeding	10	10
Bacterial Infection	10	10
Pain	9	9
Laceration(s)	9	9
Unspecified Infection	8	8
Hematoma	8	8
Osteopenia/ Osteoporosis	8	8
Thrombosis/Thrombus	7	7
Discomfort	5	5
Sinus Perforation	5	5
Inflammation	5	5
Air Embolism	5	5
Swelling/ Edema	4	4
Physical Asymmetry	4	4
Aspiration/Inhalation	3	3
Osteolysis	3	3
Abscess	3	3
Sepsis	2	2
Unspecified Tissue Injury	2	2
Pseudoaneurysm	2	2
Granuloma	2	2
Bruise/Contusion	2	2
Device Embedded In Tissue or Plaque	2	2
Taste Disorder	1	1
Implant Pain	1	1
Ischemic Heart Disease	1	1
Bone Fracture(s)	1	1
Paresthesia	1	1
Burning Sensation	1	1
Vascular Dissection	1	1
Inadequate Osseointegration	1	1
Nerve Damage	1	1
Dry Mouth	1	1
Speech Disorder	1	1
Organ Dehiscence	1	1
Hypersensitivity/Allergic reaction	1	1
Patient Problem/Medical Problem	1	1
Erosion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Implant Direct Sybron Manufacturing, LLC	II	Jan-08-2020
2	Implant Direct Sybron Manufacturing, LLC	II	Oct-31-2019
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	Straumann USA LLC	II	Aug-03-2021
7	Thommen Medical AG	II	Mar-20-2024
8	Thommen Medical AG	II	May-22-2019