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	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	2395	17890
Fracture	1601	1844
Flaked	552	17837
Vibration	294	294
Detachment of Device or Device Component	248	555
No Apparent Adverse Event	224	224
Break	215	215
Excessive Heating	202	202
Material Fragmentation	147	149
Noise, Audible	132	132
Device Remains Activated	55	56
Mechanical Jam	51	51
Device Alarm System	51	51
Separation Problem	49	51
Naturally Worn	45	45
Fluid/Blood Leak	42	60
Loss of Power	39	39
Electrical /Electronic Property Problem	37	37
Difficult to Remove	34	34
Complete Loss of Power	30	30
Dull, Blunt	28	28
Physical Resistance/Sticking	28	28
Use of Device Problem	28	28
Connection Problem	27	27
Material Twisted/Bent	27	375
Appropriate Term/Code Not Available	26	26
Difficult to Insert	24	24
Adverse Event Without Identified Device or Use Problem	22	22
Fail-Safe Did Not Operate	20	20
Material Deformation	18	23
Mechanical Problem	17	17
Material Disintegration	17	19
Smoking	17	17
Device Displays Incorrect Message	16	16
Self-Activation or Keying	16	16
Material Frayed	15	15
Device-Device Incompatibility	14	14
Delivered as Unsterile Product	14	16
Unintended Movement	13	13
Entrapment of Device	12	12
Unintended System Motion	11	11
Corroded	10	60
Material Integrity Problem	9	9
Intermittent Loss of Power	9	9
Premature Separation	9	9
Leak/Splash	8	8
Fitting Problem	7	7
Misconnection	7	7
Output below Specifications	6	6
Insufficient Information	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5683	39338
Insufficient Information	224	4146
Burn(s)	60	1837
Device Embedded In Tissue or Plaque	56	56
Foreign Body In Patient	56	58
Unintended Radiation Exposure	28	28
Superficial (First Degree) Burn	20	749
Hemorrhage/Bleeding	11	11
Unspecified Tissue Injury	11	12
Spinal Cord Injury	9	9
Pain	7	7
No Consequences Or Impact To Patient	6	6
Perforation	6	6
Partial thickness (Second Degree) Burn	5	171
Cerebrospinal Fluid Leakage	5	5
Numbness	4	4
Chemical Exposure	4	4
Hematoma	4	4
Nicks, cuts or tears of dura or other tissues by device	4	4
Nerve Damage	3	3
Paresis	3	3
Awareness during Anaesthesia	2	2
Laceration(s)	2	2
Abrasion	2	2
Perforation of Vessels	2	2
Swelling/ Edema	2	2
Hypoesthesia	2	2
Unspecified Infection	2	2
No Known Impact Or Consequence To Patient	1	1
Epistaxis	1	1
Blister	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
Visual Impairment	1	1
Abscess	1	1
Bone Fracture(s)	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