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
MEDTRONIC POWERED SURGICAL SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
NAKANISHI INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
STRYKER INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1
SURGIFY MEDICAL OY
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	2392	16422
Fracture	1417	1643
Flaked	614	25288
Vibration	313	313
Break	241	247
Detachment of Device or Device Component	197	323
Excessive Heating	192	192
Material Fragmentation	165	165
Noise, Audible	123	123
No Apparent Adverse Event	99	99
Physical Resistance/Sticking	57	57
Material Twisted/Bent	50	698
Mechanical Jam	49	49
Separation Problem	48	48
Device Remains Activated	43	43
Electrical /Electronic Property Problem	41	41
Use of Device Problem	39	39
Mechanical Problem	38	38
Connection Problem	33	33
Fluid/Blood Leak	32	43
Smoking	31	31
Loss of Power	31	31
Naturally Worn	26	26
Device Alarm System	26	26
Complete Loss of Power	25	25
Dull, Blunt	24	24
Difficult to Remove	22	22
Appropriate Term/Code Not Available	20	20
Adverse Event Without Identified Device or Use Problem	20	20
Material Deformation	17	22
Material Disintegration	15	17
Defective Component	15	15
Delivered as Unsterile Product	15	17
Self-Activation or Keying	13	13
Device Displays Incorrect Message	13	13
Material Integrity Problem	13	13
Difficult to Insert	13	13
Unintended Movement	12	12
Device-Device Incompatibility	12	12
Unintended System Motion	11	11
Entrapment of Device	11	11
Material Separation	11	11
Fail-Safe Did Not Operate	10	10
Intermittent Loss of Power	10	10
Corroded	9	59
Display or Visual Feedback Problem	9	9
Insufficient Information	9	9
Fitting Problem	8	8
Tear, Rip or Hole in Device Packaging	8	10
Premature Separation	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4890	41286
No Consequences Or Impact To Patient	396	2724
No Patient Involvement	308	7384
No Known Impact Or Consequence To Patient	189	893
Insufficient Information	148	3458
Foreign Body In Patient	57	59
Device Embedded In Tissue or Plaque	53	53
Burn(s)	53	1499
Unintended Radiation Exposure	30	30
Superficial (First Degree) Burn	19	618
No Information	16	126
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	5	5
Cerebrospinal Fluid Leakage	4	4
Numbness	4	4
Nerve Damage	3	3
Abrasion	3	3
Paresis	3	3
Blood Loss	2	2
Hematoma	2	2
Awareness during Anaesthesia	2	2
Laceration(s)	2	2
Perforation of Vessels	2	2
Swelling/ Edema	2	2
Hypoesthesia	2	2
Patient Problem/Medical Problem	2	2
Unspecified Infection	2	2
Cerebral Hyperperfusion Syndrome	1	1
Intracranial Hemorrhage	1	1
Paralysis	1	1
Bone Fracture(s)	1	1
Exposure to Body Fluids	1	1
Erythema	1	1
Alteration in Body Temperature	1	1
Necrosis	1	1
Visual Impairment	1	1
Abscess	1	1
Nicks, cuts or tears of dura or other tissues by device	1	1
No Code Available	1	1
Tissue Damage	1	1
Partial thickness (Second Degree) Burn	1	1
Radiation Exposure, Unintended	1	1
Pulmonary Dysfunction	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Full thickness (Third Degree) Burn	1	1