TPLC - Total Product Life Cycle

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Device	handpiece, rotary bone cutting
Product Code	KMW
Regulation Number	872.4120
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	138	138
Nonstandard Device	22	22
Temperature Problem	19	19
Power Problem	11	11
Detachment of Device or Device Component	5	5
Break	3	3
Use of Device Problem	3	3
Mechanical Problem	2	2
Unintended Power Up	2	2
Failure to Deliver Energy	1	1
Output Problem	1	1
Unintended Electrical Shock	1	1
Insufficient Information	1	1
Noise, Audible	1	1
Failure to Power Up	1	1
Material Too Rigid or Stiff	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Vibration	1	1
Improper or Incorrect Procedure or Method	1	1
Intermittent Loss of Power	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	92	92
Partial thickness (Second Degree) Burn	42	42
Superficial (First Degree) Burn	26	26
No Clinical Signs, Symptoms or Conditions	16	16
Burn, Thermal	11	11
Insufficient Information	11	11
Injury	9	9
Patient Problem/Medical Problem	8	8
Full thickness (Third Degree) Burn	3	3
Erythema	2	2
Swelling	2	2
Electric Shock	1	1
Abrasion	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