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	2886	19820
Fracture	1732	2009
Detachment of Device or Device Component	1110	1490
No Apparent Adverse Event	864	864
Naturally Worn	600	600
Flaked	580	18052
Vibration	440	443
Difficult to Insert	343	343
Excessive Heating	216	216
Noise, Audible	201	201
Break	186	186
Material Fragmentation	161	163
Difficult to Remove	157	157
Loss of Power	148	148
Physical Resistance/Sticking	87	87
Corroded	59	59
Device Remains Activated	58	59
Mechanical Jam	57	57
Device Alarm System	55	55
Fluid/Blood Leak	51	69
Separation Problem	50	52
Material Deformation	43	48
Electrical /Electronic Property Problem	38	38
Material Twisted/Bent	37	384
Use of Device Problem	32	32
Complete Loss of Power	32	32
Fail-Safe Did Not Operate	31	31
Dull, Blunt	30	30
Connection Problem	29	29
Appropriate Device Problem Term/Code Not Available	29	29
Adverse Event Without Identified Device or Use Problem	24	24
Material Frayed	23	23
Mechanical Problem	21	21
Self-Activation or Keying	21	21
Loose or Intermittent Connection	19	19
Material Integrity Problem	19	19
Smoking	18	18
Device Displays Incorrect Message	17	17
Material Disintegration	17	19
Insufficient Device Problem Information	16	16
Device-Device Incompatibility	16	16
Delivered as Unsterile Product	15	17
Unintended Movement	14	14
Unintended System Motion	12	12
Leak/Splash	11	11
Intermittent Loss of Power	9	9
Premature Separation	9	9
Output below Specifications	8	8
Power Problem	7	7
Device Reprocessing Problem	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8958	44415
Insufficient Information	455	4661
Burn(s)	64	1933
Device Embedded In Tissue or Plaque	62	62
Foreign Body In Patient	61	68
Unintended Radiation Exposure	37	37
Superficial (First Degree) Burn	21	840
Hemorrhage/Blood Loss/Bleeding	13	13
Unspecified Tissue Injury	12	13
Spinal Cord Injury	9	9
Perforation	7	7
Pain	7	7
No Consequences Or Impact To Patient	6	6
Cerebrospinal Fluid Leakage	5	5
Dural Tear	5	5
Partial thickness (Second Degree) Burn	5	171
Chemical Exposure	5	5
Hematoma	4	4
Numbness	4	4
Paresis	3	3
Nerve Damage	3	3
Laceration(s)	2	2
Swelling/ Edema	2	2
Abrasion	2	2
Unspecified Infection	2	2
Perforation of Vessels	2	2
Hypoesthesia	2	2
Awareness during Anaesthesia	2	2
Bone Fracture(s)	1	1
Erythema	1	1
Impaired Healing	1	1
Necrosis	1	1
Intracranial Hemorrhage	1	1
Paralysis	1	1
No Known Impact Or Consequence To Patient	1	1
Epistaxis	1	1
Pulmonary Dysfunction	1	1
Abscess	1	1
Full thickness (Third Degree) Burn	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Cerebral Hyperperfusion Syndrome	1	1
Blister	1	1
Alteration in Body Temperature	1	1
Urinary Frequency / Polyuria	1	1
Visual Impairment	1	1
Septic loosening	1	1
Facial Paralysis	1	1
Abnormal mucus discharge	1	1
Intracranial Pressure Increased	1	1
Hormonal Imbalance	1	1