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	831	1297
Detachment of Device or Device Component	604	639
No Apparent Adverse Event	194	194
Output below Specifications	179	179
Material Puncture/Hole	141	141
Difficult to Insert	104	104
Noise, Audible	89	89
Fluid/Blood Leak	88	414
Naturally Worn	83	83
Vibration	70	70
Break	66	65
Fracture	54	54
Loss of Power	50	50
Difficult to Remove	49	49
Physical Resistance/Sticking	46	47
Unintended System Motion	45	45
Material Twisted/Bent	43	43
Excessive Heating	40	40
Device Remains Activated	35	35
Complete Loss of Power	33	33
Corroded	31	31
Electrical /Electronic Property Problem	29	29
Burst Container or Vessel	25	36
Appropriate Term/Code Not Available	19	19
Leak/Splash	16	16
Fail-Safe Did Not Operate	16	16
Mechanical Jam	13	13
Unintended Power Up	12	20
Premature Separation	11	11
Smoking	10	10
Material Deformation	10	10
Adverse Event Without Identified Device or Use Problem	10	10
Misconnection	10	10
Device Displays Incorrect Message	9	9
Material Rupture	9	9
Fail-Safe Problem	7	10
Material Fragmentation	6	6
Insufficient Information	5	5
Gas/Air Leak	4	4
Energy Output Problem	4	4
Device-Device Incompatibility	4	4
Degraded	3	3
Material Integrity Problem	3	3
Failure to Auto Stop	3	3
Mechanical Problem	3	3
Dull, Blunt	3	3
Device Contaminated During Manufacture or Shipping	3	3
Explosion	2	2
Device Reprocessing Problem	2	2
Defective Component	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2075	2899
No Consequences Or Impact To Patient	164	186
Insufficient Information	71	207
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
Device Embedded In Tissue or Plaque	8	8
Perforation	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
Foreign Body In Patient	1	1
Oversedation	1	1
Intracranial Hemorrhage	1	1
Numbness	1	1
Laceration(s)	1	1
Awareness during Anaesthesia	1	1
Reaction	1	1
Partial thickness (Second Degree) Burn	1	3
Headache	1	1