TPLC - Total Product Life Cycle

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Device	motor, drill, pneumatic
Regulation Description	Pneumatic cranial drill motor.
Product Code	HBB
Regulation Number	882.4370
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	795	1261
Detachment of Device or Device Component	577	612
No Apparent Adverse Event	183	183
Output below Specifications	179	179
Material Puncture/Hole	141	141
Difficult to Insert	97	97
Fluid/Blood Leak	88	414
Noise, Audible	86	86
Naturally Worn	82	82
Vibration	65	65
Break	63	62
Fracture	48	48
Difficult to Remove	48	48
Loss of Power	46	46
Physical Resistance/Sticking	45	46
Material Twisted/Bent	43	43
Unintended System Motion	42	42
Excessive Heating	39	39
Device Remains Activated	32	32
Complete Loss of Power	32	32
Corroded	31	31
Electrical /Electronic Property Problem	29	29
Burst Container or Vessel	25	36
Appropriate Term/Code Not Available	18	18
Leak/Splash	16	16
Unintended Power Up	12	20
Mechanical Jam	12	12
Fail-Safe Did Not Operate	11	11
Adverse Event Without Identified Device or Use Problem	10	10
Misconnection	10	10
Material Deformation	10	10
Premature Separation	10	10
Material Rupture	9	9
Device Displays Incorrect Message	8	8
Fail-Safe Problem	7	10
Material Fragmentation	6	6
Insufficient Information	5	5
Smoking	4	4
Gas/Air Leak	4	4
Energy Output Problem	4	4
Material Integrity Problem	3	3
Degraded	3	3
Failure to Auto Stop	3	3
Mechanical Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3
Dull, Blunt	3	3
Device-Device Incompatibility	3	3
Device Reprocessing Problem	2	2
Intermittent Loss of Power	2	2
Defective Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1979	2803
No Consequences Or Impact To Patient	164	186
Insufficient Information	52	188
No Patient Involvement	35	120
Burn(s)	14	14
Chemical Exposure	13	13
Unintended Radiation Exposure	12	12
No Known Impact Or Consequence To Patient	11	11
Perforation	7	7
Device Embedded In Tissue or Plaque	7	7
Injury	6	6
Unspecified Tissue Injury	6	6
Cerebrospinal Fluid Leakage	6	6
Hearing Impairment	5	5
Unspecified Infection	5	5
Tissue Damage	5	5
Hemorrhage/Bleeding	5	5
Spinal Column Injury	4	4
Nerve Damage	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Tinnitus	3	3
Pain	2	2
Spinal Cord Injury	2	2
Muscle Weakness	1	1
Intracranial Hemorrhage	1	1
Oversedation	1	1
Foreign Body In Patient	1	1
Numbness	1	1
Awareness during Anaesthesia	1	1
Laceration(s)	1	1
Reaction	1	1
Partial thickness (Second Degree) Burn	1	3
Headache	1	1