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	171	174
Failure to Cut	71	71
Device-Device Incompatibility	38	39
Entrapment of Device	34	34
Overheating of Device	13	13
Fracture	8	9
Material Deformation	7	7
Noise, Audible	5	5
Excessive Heating	5	5
Defective Device	4	4
Contamination /Decontamination Problem	4	4
Complete Loss of Power	3	3
No Apparent Adverse Event	3	3
Separation Failure	3	3
Appropriate Term/Code Not Available	2	3
Component or Accessory Incompatibility	2	2
Detachment of Device or Device Component	2	3
Material Twisted/Bent	2	2
Material Fragmentation	2	2
Mechanical Problem	1	2
Inadequacy of Device Shape and/or Size	1	1
Failure to Osseointegrate	1	1
Improper or Incorrect Procedure or Method	1	1
Dull, Blunt	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Material Integrity Problem	1	2
Insufficient Information	1	1
Premature Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	226	230
Insufficient Information	41	42
Foreign Body In Patient	32	32
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
Laceration(s)	1	1
Pain	1	1
Hemorrhage/Bleeding	1	1