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	147	147
Nonstandard Device	20	20
Temperature Problem	13	13
Power Problem	11	11
Detachment of Device or Device Component	5	5
Break	3	3
Mechanical Problem	2	2
Unintended Power Up	2	2
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
Intermittent Loss of Power	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	91	91
Partial thickness (Second Degree) Burn	53	53
Superficial (First Degree) Burn	25	25
No Clinical Signs, Symptoms or Conditions	17	17
Insufficient Information	11	11
Full thickness (Third Degree) Burn	4	4
Burn, Thermal	3	3
Patient Problem/Medical Problem	2	2
Injury	2	2
Erythema	2	2
Swelling	2	2
Electric Shock	1	1
Scarring	1	1
Blister	1	1
No Known Impact Or Consequence To Patient	1	1
Burning Sensation	1	1
Numbness	1	1
Unspecified Tissue Injury	1	1
No Consequences Or Impact To Patient	1	1