TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
DENT4YOU AG
	SUBSTANTIALLY EQUIVALENT	1
E.M.S ELECTRO MEDICAL SYSTEMS S.A
	SUBSTANTIALLY EQUIVALENT	1
E.M.S ELECTRO MEDICAL SYSTEMS S.A.
	SUBSTANTIALLY EQUIVALENT	1
ENGINEERED ENDODONTICS
	SUBSTANTIALLY EQUIVALENT	1
ESSENTIAL DENTAL SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN COXO MEDICAL INSTRUMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUILIN REFINE MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MECTRON S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
ODNE AG
	SUBSTANTIALLY EQUIVALENT	1
SATELEC-ACTEON GROUP
	SUBSTANTIALLY EQUIVALENT	1
SCHLUMBOHM GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN MICRO ELECTRIC INTELLIGENCE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SONENDO, INC
	SUBSTANTIALLY EQUIVALENT	1
SONENDO, INC.
	SUBSTANTIALLY EQUIVALENT	1
TTBIO CORP.
	SUBSTANTIALLY EQUIVALENT	2
W&H DENTALWERK BUERMOSS GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	500	500
Break	386	386
Restricted Flow rate	257	257
No Flow	78	78
Temperature Problem	42	42
Infusion or Flow Problem	14	14
Insufficient Information	9	9
Excessive Heating	7	7
Material Fragmentation	7	7
Unintended Electrical Shock	6	6
Improper Flow or Infusion	6	6
Detachment of Device or Device Component	5	5
Fracture	4	4
Mechanical Problem	4	4
Fluid/Blood Leak	3	3
Component Missing	3	3
Therapeutic or Diagnostic Output Failure	3	3
Defective Device	3	3
Patient-Device Incompatibility	3	3
Moisture or Humidity Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Melted	2	2
Ejection Problem	2	2
Difficult to Remove	2	2
Device Emits Odor	2	2
Power Problem	2	2
Insufficient Flow or Under Infusion	1	1
Difficult to Insert	1	1
Thermal Decomposition of Device	1	1
Decrease in Pressure	1	1
Naturally Worn	1	1
Electrical /Electronic Property Problem	1	1
Loose or Intermittent Connection	1	1
Obstruction of Flow	1	1
Use of Device Problem	1	1
Material Twisted/Bent	1	1
Smoking	1	1
Vibration	1	1
Activation Problem	1	1
Output Problem	1	1
Complete Blockage	1	1
Product Quality Problem	1	1
Leak/Splash	1	1
Separation Problem	1	1
Sparking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	674	674
No Consequences Or Impact To Patient	362	362
Insufficient Information	94	94
No Known Impact Or Consequence To Patient	31	31
No Information	21	21
Foreign Body In Patient	14	14
Burn(s)	12	12
Device Embedded In Tissue or Plaque	11	11
Injury	4	4
Pain	4	4
Needle Stick/Puncture	3	3
Swelling	3	3
Numbness	3	3
Sensitivity of Teeth	3	3
Patient Problem/Medical Problem	2	2
Superficial (First Degree) Burn	2	2
Burn, Thermal	2	2
No Patient Involvement	2	2
Laceration(s)	2	2
Hemorrhage/Bleeding	2	2
Tinnitus	2	2
Dysphasia	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Electric Shock	1	1
No Code Available	1	1
Bowel Perforation	1	1
Sinus Perforation	1	1
Skin Discoloration	1	1
Dyspnea	1	1
Fluid Discharge	1	1
Undesired Nerve Stimulation	1	1
Unspecified Tissue Injury	1	1
Skin Burning Sensation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Dental EZ Group Star Dental Division	II	Jun-24-2024
2	Electro Medical Systems SA	II	Apr-24-2024
3	Sonendo Inc	II	Nov-14-2022
4	Sonendo Inc	II	May-28-2020