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	157	157
Nonstandard Device	20	20
Temperature Problem	14	14
Power Problem	11	11
Detachment of Device or Device Component	7	7
Break	3	3
Mechanical Problem	2	2
Unintended Power Up	2	2
Material Fragmentation	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
Fracture	1	1
Intermittent Loss of Power	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Burn(s)	98	98
Partial thickness (Second Degree) Burn	57	57
Superficial (First Degree) Burn	25	25
No Clinical Signs, Symptoms or Conditions	19	19
Insufficient Information	11	11
Full thickness (Third Degree) Burn	5	5
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
Foreign Body In Patient	1	1
Numbness	1	1
Unspecified Tissue Injury	1	1
No Consequences Or Impact To Patient	1	1
Device Embedded In Tissue or Plaque	1	1