TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
DENJOY DENTAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DENT4YOU AG
	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
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	424	424
Break	335	335
Restricted Flow rate	253	253
No Flow	141	141
Temperature Problem	37	37
Insufficient Information	12	12
Infusion or Flow Problem	8	8
Excessive Heating	7	7
Detachment of Device or Device Component	7	7
Unintended Electrical Shock	6	6
Mechanical Problem	4	4
Fracture	4	4
Improper Flow or Infusion	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Patient-Device Incompatibility	3	3
Use of Device Problem	3	3
Component Missing	3	3
Fluid/Blood Leak	2	2
Melted	2	2
Material Integrity Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Difficult to Remove	2	2
Moisture or Humidity Problem	2	2
Improper or Incorrect Procedure or Method	1	1
Loose or Intermittent Connection	1	1
Naturally Worn	1	1
Power Problem	1	1
Product Quality Problem	1	1
Device Emits Odor	1	1
Lack of Effect	1	1
Insufficient Flow or Under Infusion	1	1
Thermal Decomposition of Device	1	1
Material Twisted/Bent	1	1
Obstruction of Flow	1	1
Fail-Safe Problem	1	1
Difficult to Insert	1	1
Material Fragmentation	1	1
Patient Device Interaction Problem	1	1
Defective Device	1	1
Complete Blockage	1	1
Activation Problem	1	1
Output Problem	1	1
Separation Problem	1	1
Pressure Problem	1	1
Chemical Problem	1	1
Sparking	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	880	880
Insufficient Information	98	98
No Consequences Or Impact To Patient	95	95
Burn(s)	16	16
Foreign Body In Patient	13	13
No Known Impact Or Consequence To Patient	11	11
Device Embedded In Tissue or Plaque	11	11
Hemorrhage/Bleeding	5	5
Nerve Damage	4	4
Pain	4	4
Laceration(s)	4	4
Caustic/Chemical Burns	4	4
No Information	3	3
Sinus Perforation	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
Injury	2	2
No Patient Involvement	2	2
Discomfort	2	2
Blurred Vision	2	2
Neuralgia	2	2
Increased Sensitivity	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
Burn, Thermal	1	1
Skin Discoloration	1	1
Burning Sensation	1	1
Dyspnea	1	1
Fluid Discharge	1	1
Undesired Nerve Stimulation	1	1
Unspecified Tissue Injury	1	1
Tinnitus	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