TPLC - Total Product Life Cycle

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Device	handpiece, rotary bone cutting
Regulation Description	Bone cutting instrument and accessories.
Product Code	KMW
Regulation Number	872.4120
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	152	152
Nonstandard Device	16	16
Temperature Problem	13	13
Power Problem	11	11
Detachment of Device or Device Component	7	7
Break	3	3
Unintended Power Up	2	2
Material Fragmentation	2	2
Mechanical Problem	1	1
Output Problem	1	1
Unintended Electrical Shock	1	1
Insufficient Information	1	1
Vibration	1	1
Failure to Power Up	1	1
Use of Device Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Fracture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	96	96
Partial thickness (Second Degree) Burn	59	59
Superficial (First Degree) Burn	22	22
No Clinical Signs, Symptoms or Conditions	19	19
Insufficient Information	11	11
Full thickness (Third Degree) Burn	5	5
Erythema	2	2
Electric Shock	1	1
Scarring	1	1
Burn, Thermal	1	1
Blister	1	1
Burning Sensation	1	1
Foreign Body In Patient	1	1
Numbness	1	1
Unspecified Tissue Injury	1	1
Device Embedded In Tissue or Plaque	1	1