TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BENNETT JACOBY, DDS, MS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
	SUBSTANTIALLY EQUIVALENT	2
MECTRON S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
SAESHIN PRECISION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	179	179
Failure to Cut	65	65
Device-Device Incompatibility	47	47
Entrapment of Device	43	43
Fracture	8	8
Material Deformation	7	7
Overheating of Device	6	6
Defective Device	4	4
Contamination /Decontamination Problem	4	4
Noise, Audible	4	4
Separation Failure	3	3
No Apparent Adverse Event	3	3
Component or Accessory Incompatibility	2	2
Material Fragmentation	2	2
Material Twisted/Bent	2	2
Detachment of Device or Device Component	2	3
Mechanical Problem	1	1
Material Integrity Problem	1	1
Positioning Problem	1	1
Failure to Osseointegrate	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Appropriate Term/Code Not Available	1	1
Excessive Heating	1	1
Improper or Incorrect Procedure or Method	1	1
Dull, Blunt	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	188	189
Foreign Body In Patient	44	44
Insufficient Information	40	40
No Consequences Or Impact To Patient	27	27
Failure of Implant	16	16
No Code Available	10	10
Burn(s)	6	6
Injury	3	3
Unspecified Tissue Injury	3	3
Unspecified Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Osteopenia/ Osteoporosis	1	1
No Known Impact Or Consequence To Patient	1	1
Pain	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Nobel Biocare Usa Llc	II	Feb-19-2020