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	2
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	4

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	2495	18754
Fracture	1666	1920
Flaked	577	18048
Vibration	322	322
Detachment of Device or Device Component	318	669
No Apparent Adverse Event	293	293
Break	222	222
Excessive Heating	210	210
Material Fragmentation	154	156
Noise, Audible	143	143
Naturally Worn	79	79
Device Remains Activated	57	58
Mechanical Jam	56	56
Device Alarm System	55	55
Loss of Power	52	52
Separation Problem	50	52
Difficult to Insert	48	48
Fluid/Blood Leak	44	62
Difficult to Remove	42	42
Physical Resistance/Sticking	41	41
Electrical /Electronic Property Problem	37	37
Use of Device Problem	32	32
Complete Loss of Power	31	31
Dull, Blunt	30	30
Corroded	30	80
Appropriate Term/Code Not Available	29	29
Connection Problem	28	28
Material Twisted/Bent	27	375
Adverse Event Without Identified Device or Use Problem	23	23
Fail-Safe Did Not Operate	23	23
Mechanical Problem	19	19
Material Deformation	19	24
Material Frayed	18	18
Smoking	17	17
Material Disintegration	17	19
Self-Activation or Keying	17	17
Device Displays Incorrect Message	16	16
Device-Device Incompatibility	15	15
Unintended Movement	14	14
Delivered as Unsterile Product	14	16
Entrapment of Device	13	13
Unintended System Motion	12	12
Leak/Splash	10	10
Material Integrity Problem	9	9
Intermittent Loss of Power	9	9
Premature Separation	9	9
Output below Specifications	8	8
Fitting Problem	7	7
Misconnection	7	7
Insufficient Information	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6103	40762
Insufficient Information	273	4278
Device Embedded In Tissue or Plaque	60	60
Burn(s)	60	1837
Foreign Body In Patient	58	60
Unintended Radiation Exposure	32	32
Superficial (First Degree) Burn	20	749
Hemorrhage/Bleeding	12	12
Unspecified Tissue Injury	11	12
Spinal Cord Injury	9	9
Perforation	7	7
Pain	7	7
No Consequences Or Impact To Patient	6	6
Cerebrospinal Fluid Leakage	5	5
Nicks, cuts or tears of dura or other tissues by device	5	5
Chemical Exposure	4	4
Numbness	4	4
Hematoma	4	4
Partial thickness (Second Degree) Burn	4	170
Nerve Damage	3	3
Paresis	3	3
Abrasion	2	2
Awareness during Anaesthesia	2	2
Laceration(s)	2	2
Perforation of Vessels	2	2
Swelling/ Edema	2	2
Hypoesthesia	2	2
Unspecified Infection	2	2
Blister	1	1
No Known Impact Or Consequence To Patient	1	1
Epistaxis	1	1
Cerebral Hyperperfusion Syndrome	1	1
Intracranial Hemorrhage	1	1
Paralysis	1	1
Exposure to Body Fluids	1	1
Erythema	1	1
Alteration in Body Temperature	1	1
Bone Fracture(s)	1	1
Visual Impairment	1	1
Abscess	1	1
Necrosis	1	1
Pulmonary Dysfunction	1	1
Urinary Frequency	1	1
Hormonal Imbalance	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Full thickness (Third Degree) Burn	1	1
Impaired Healing	1	1