TPLC - Total Product Life Cycle

• Device: locator, root apex
• Product Code: LQY
• Device Class: Unclassified

Premarket Reviews
Manufacturer	Decision
CEFLA S.C.
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU BOMEDENT MEDICAL TECHNOLOGY CO.,LTD
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU HAILI MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN COXO MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
META SYSTEMS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN ROGIN MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2021	107	107
2022	63	63
2023	56	56
2024	81	81
2025	52	52
2026	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Incorrect Measurement	361	361
Incorrect, Inadequate or Imprecise Result or Readings	16	16
Output Problem	4	4
Break	1	1
No Display/Image	1	1
Mechanical Problem	1	1
Communication or Transmission Problem	1	1
Device Markings/Labelling Problem	1	1
Unintended Electrical Shock	1	1
Patient-Device Incompatibility	1	1
Insufficient Information	1	1
Defective Device	1	1
Unexpected Therapeutic Results	1	1
Electrical /Electronic Property Problem	1	1
Device Displays Incorrect Message	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	314	314
Insufficient Information	95	95
Pain	4	4
Needle Stick/Puncture	1	1
Device Embedded In Tissue or Plaque	1	1
Swelling/ Edema	1	1
Hemorrhage/Bleeding	1	1
Hypersensitivity/Allergic reaction	1	1
Undesired Nerve Stimulation	1	1