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	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	2510	17461
Fracture	1602	1838
Flaked	636	25574
Vibration	335	335
Break	256	262
Detachment of Device or Device Component	231	418
Excessive Heating	219	219
Material Fragmentation	171	171
Noise, Audible	132	132
No Apparent Adverse Event	110	110
Physical Resistance/Sticking	57	57
Device Remains Activated	54	54
Mechanical Jam	52	52
Material Twisted/Bent	50	698
Separation Problem	49	49
Electrical /Electronic Property Problem	41	41
Use of Device Problem	40	40
Mechanical Problem	40	40
Fluid/Blood Leak	39	50
Device Alarm System	35	35
Loss of Power	34	34
Smoking	34	34
Connection Problem	34	34
Naturally Worn	32	32
Complete Loss of Power	30	30
Difficult to Remove	28	28
Dull, Blunt	27	27
Appropriate Term/Code Not Available	26	26
Adverse Event Without Identified Device or Use Problem	22	22
Difficult to Insert	20	20
Material Deformation	17	22
Delivered as Unsterile Product	16	18
Material Disintegration	16	18
Defective Component	15	15
Self-Activation or Keying	14	14
Device Displays Incorrect Message	14	14
Device-Device Incompatibility	14	14
Unintended Movement	13	13
Material Integrity Problem	13	13
Fail-Safe Did Not Operate	12	12
Unintended System Motion	11	11
Entrapment of Device	11	11
Material Separation	11	11
Corroded	10	60
Intermittent Loss of Power	10	10
Insufficient Information	9	9
Display or Visual Feedback Problem	9	9
Material Frayed	9	9
Premature Separation	8	8
Fitting Problem	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5319	42967
No Consequences Or Impact To Patient	396	2724
No Patient Involvement	308	7384
No Known Impact Or Consequence To Patient	189	893
Insufficient Information	178	3684
Foreign Body In Patient	59	61
Device Embedded In Tissue or Plaque	57	57
Burn(s)	56	1550
Unintended Radiation Exposure	31	31
Superficial (First Degree) Burn	20	761
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
Cerebrospinal Fluid Leakage	5	5
Pain	5	5
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
Partial thickness (Second Degree) Burn	2	38
Perforation of Vessels	2	2
Swelling/ Edema	2	2
Awareness during Anaesthesia	2	2
Laceration(s)	2	2
Blood Loss	2	2
Unspecified Infection	2	2
Patient Problem/Medical Problem	2	2
Alteration in Body Temperature	1	1
Exposure to Body Fluids	1	1
Erythema	1	1
Paralysis	1	1
Visual Impairment	1	1
Intracranial Hemorrhage	1	1
Abscess	1	1
Epistaxis	1	1
Cerebral Hyperperfusion Syndrome	1	1
Tissue Damage	1	1
Bone Fracture(s)	1	1
Necrosis	1	1
No Code Available	1	1
Radiation Exposure, Unintended	1	1
Pulmonary Dysfunction	1	1
Urinary Frequency	1	1