TPLC - Total Product Life Cycle

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Device	drill, bone, powered
Regulation Description	Bone cutting instrument and accessories.
Product Code	DZI
Regulation Number	872.4120
Device Class	2

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	200	203
Failure to Cut	71	71
Device-Device Incompatibility	51	52
Entrapment of Device	46	46
Overheating of Device	12	12
Fracture	8	9
Material Deformation	7	7
Excessive Heating	5	5
Noise, Audible	5	5
Defective Device	4	4
Contamination /Decontamination Problem	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
Appropriate Term/Code Not Available	2	3
Complete Loss of Power	2	2
Mechanical Problem	1	2
Material Integrity Problem	1	2
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
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	219	223
Foreign Body In Patient	47	47
Insufficient Information	41	42
No Consequences Or Impact To Patient	27	27
Failure of Implant	16	17
No Code Available	10	10
Burn(s)	7	7
Injury	3	3
Unspecified Tissue Injury	3	3
Unspecified Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	2
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