TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO.,LTD
	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
SATELEC-ACTEON GROUP
	SUBSTANTIALLY EQUIVALENT	1
SCHLUMBOHM GMBH & CO. KG
	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	449	449
Break	371	371
Restricted Flow rate	235	235
No Flow	60	60
Temperature Problem	38	38
Infusion or Flow Problem	14	14
Insufficient Information	8	8
Excessive Heating	7	7
Material Fragmentation	7	7
Improper Flow or Infusion	6	6
Unintended Electrical Shock	6	6
Detachment of Device or Device Component	4	4
Fracture	4	4
Mechanical Problem	4	4
Fluid/Blood Leak	3	3
Patient-Device Incompatibility	3	3
Defective Device	3	3
Component Missing	3	3
Therapeutic or Diagnostic Output Failure	3	3
Ejection Problem	2	2
Power Problem	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Moisture or Humidity Problem	2	2
Melted	2	2
Device Emits Odor	2	2
Difficult to Remove	2	2
Smoking	1	1
Use of Device Problem	1	1
Vibration	1	1
Insufficient Flow or Under Infusion	1	1
Difficult to Insert	1	1
Leak/Splash	1	1
Loose or Intermittent Connection	1	1
Thermal Decomposition of Device	1	1
Complete Blockage	1	1
Electrical /Electronic Property Problem	1	1
Naturally Worn	1	1
Output Problem	1	1
Material Twisted/Bent	1	1
Obstruction of Flow	1	1
Decrease in Pressure	1	1
Product Quality Problem	1	1
Sparking	1	1
Activation Problem	1	1
Separation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	589	589
No Consequences Or Impact To Patient	362	362
Insufficient Information	89	89
No Known Impact Or Consequence To Patient	31	31
No Information	21	21
Foreign Body In Patient	12	12
Device Embedded In Tissue or Plaque	11	11
Burn(s)	11	11
Pain	4	4
Injury	4	4
Numbness	3	3
Needle Stick/Puncture	3	3
Swelling	3	3
Tinnitus	2	2
Hemorrhage/Bleeding	2	2
Burn, Thermal	2	2
No Patient Involvement	2	2
Patient Problem/Medical Problem	2	2
No Code Available	1	1
Skin Burning Sensation	1	1
Unspecified Tissue Injury	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Bowel Perforation	1	1
Fluid Discharge	1	1
Electric Shock	1	1
Sensitivity of Teeth	1	1
Sinus Perforation	1	1
Undesired Nerve Stimulation	1	1
Dyspnea	1	1
Dysphasia	1	1
Skin Discoloration	1	1