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
GUANGDONG JINME MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
IMPLANT DIRECT SYBRON MANUFACTURING, LLC
	SUBSTANTIALLY EQUIVALENT	1
MECTRON S.P.A.
	SUBSTANTIALLY EQUIVALENT	1
NAKANISHI, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	168	171
Failure to Cut	69	69
Device-Device Incompatibility	36	37
Entrapment of Device	33	33
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
Complete Loss of Power	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
Mechanical Problem	1	2
Material Integrity Problem	1	2
Failure to Osseointegrate	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Premature Separation	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	221	225
Insufficient Information	41	42
Foreign Body In Patient	31	31
Failure of Implant	14	15
Burn(s)	7	7
Unspecified Tissue Injury	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	2
Osteopenia/ Osteoporosis	1	1
Pain	1	1