TPLC - Total Product Life Cycle

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Device	drills, burrs, trephines & accessories (simple, powered)
Regulation Description	Powered simple cranial drills, burrs, trephines, and their accessories.
Product Code	HBE
Regulation Number	882.4310
Device Class	2

Premarket Reviews
Manufacturer	Decision
ADEOR MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET MICOFIXATION
	SUBSTANTIALLY EQUIVALENT	1
BIOMET MICROFIXATION
	SUBSTANTIALLY EQUIVALENT	2
HUBLY INC.
	SUBSTANTIALLY EQUIVALENT	1
HUBLY, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC POWERED SURGICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
NAKANISHI INC.
	SUBSTANTIALLY EQUIVALENT	2
PHASOR HEALTH, LLC
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1
SURGIFY MEDICAL OY
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	2673	19419
Fracture	1773	2050
Flaked	683	26144
Vibration	363	363
Detachment of Device or Device Component	275	591
Break	260	270
Excessive Heating	240	240
Material Fragmentation	172	172
No Apparent Adverse Event	168	168
Noise, Audible	148	148
Physical Resistance/Sticking	59	59
Device Remains Activated	58	58
Mechanical Jam	57	57
Material Twisted/Bent	53	701
Separation Problem	50	50
Device Alarm System	48	48
Fluid/Blood Leak	47	67
Use of Device Problem	42	42
Mechanical Problem	41	41
Electrical /Electronic Property Problem	41	41
Naturally Worn	39	39
Connection Problem	37	37
Loss of Power	36	36
Difficult to Remove	35	35
Smoking	34	34
Complete Loss of Power	31	31
Appropriate Term/Code Not Available	29	29
Dull, Blunt	27	27
Adverse Event Without Identified Device or Use Problem	23	23
Difficult to Insert	22	22
Material Deformation	18	23
Self-Activation or Keying	18	18
Material Disintegration	18	20
Delivered as Unsterile Product	17	19
Device Displays Incorrect Message	17	17
Fail-Safe Did Not Operate	17	17
Defective Component	15	15
Device-Device Incompatibility	14	14
Unintended Movement	14	14
Material Integrity Problem	13	13
Entrapment of Device	13	13
Unintended System Motion	12	12
Material Frayed	12	12
Material Separation	11	11
Intermittent Loss of Power	10	10
Corroded	10	60
Insufficient Information	9	9
Power Problem	9	9
Display or Visual Feedback Problem	9	9
Premature Separation	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5841	45985
No Consequences Or Impact To Patient	396	2724
No Patient Involvement	308	7384
Insufficient Information	219	4227
No Known Impact Or Consequence To Patient	189	893
Foreign Body In Patient	68	70
Device Embedded In Tissue or Plaque	62	62
Burn(s)	62	1875
Unintended Radiation Exposure	31	31
Superficial (First Degree) Burn	20	761
No Information	16	130
Hemorrhage/Bleeding	13	13
Injury	12	12
Unspecified Tissue Injury	11	11
Spinal Cord Injury	9	9
Chemical Exposure	9	9
Perforation	8	8
Pain	6	6
Cerebrospinal Fluid Leakage	5	5
Partial thickness (Second Degree) Burn	4	170
Numbness	4	4
Nicks, cuts or tears of dura or other tissues by device	3	3
Hematoma	3	3
Abrasion	3	3
Paresis	3	3
Nerve Damage	3	3
Hypoesthesia	2	2
Swelling/ Edema	2	2
Perforation of Vessels	2	2
Laceration(s)	2	2
Awareness during Anaesthesia	2	2
Blood Loss	2	2
Patient Problem/Medical Problem	2	2
Unspecified Infection	2	2
Erythema	1	1
Alteration in Body Temperature	1	1
Exposure to Body Fluids	1	1
Paralysis	1	1
Intracranial Hemorrhage	1	1
Epistaxis	1	1
Visual Impairment	1	1
Abscess	1	1
Blister	1	1
Cerebral Hyperperfusion Syndrome	1	1
Bone Fracture(s)	1	1
Necrosis	1	1
Tissue Damage	1	1
No Code Available	1	1
Radiation Exposure, Unintended	1	1
Pulmonary Dysfunction	1	1