TPLC - Total Product Life Cycle

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Device	drills, burrs, trephines & accessories (simple, powered)
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
AESCULAP, INC.
	SUBSTANTIALLY EQUIVALENT	2
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
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
SURGIFY MEDICAL OY
	SUBSTANTIALLY EQUIVALENT	1
THE ANSPACH EFFORT, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	2065	15453
Fracture	1320	1525
Flaked	703	31307
Break	350	398
Vibration	289	289
Detachment of Device or Device Component	199	302
Excessive Heating	177	177
Material Fragmentation	162	163
Noise, Audible	92	92
No Apparent Adverse Event	90	90
Material Twisted/Bent	70	885
Physical Resistance/Sticking	52	52
Mechanical Jam	51	51
Separation Problem	45	45
Mechanical Problem	39	39
Device Remains Activated	38	38
Use of Device Problem	38	38
Fluid/Blood Leak	34	45
Connection Problem	34	34
Electrical /Electronic Property Problem	27	27
Smoking	26	26
Adverse Event Without Identified Device or Use Problem	21	21
Dull, Blunt	21	21
Difficult to Remove	19	19
Material Deformation	18	23
Defective Component	17	17
Complete Loss of Power	16	16
Appropriate Term/Code Not Available	15	15
Material Disintegration	15	17
Material Integrity Problem	13	13
Unintended Movement	13	13
Material Separation	12	12
Delivered as Unsterile Product	11	11
Device-Device Incompatibility	11	11
Insufficient Information	11	11
Loss of Power	10	10
Entrapment of Device	10	10
Tear, Rip or Hole in Device Packaging	9	11
Self-Activation or Keying	9	9
Display or Visual Feedback Problem	9	9
Intermittent Loss of Power	9	9
Naturally Worn	8	8
Fitting Problem	8	8
Unintended System Motion	7	7
Difficult to Insert	7	7
Computer Software Problem	7	7
Mechanics Altered	7	7
Expiration Date Error	6	6
Power Problem	6	6
Premature Separation	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3738	37829
No Consequences Or Impact To Patient	773	6632
No Patient Involvement	623	14239
No Known Impact Or Consequence To Patient	366	1979
Insufficient Information	116	2766
Foreign Body In Patient	62	63
Device Embedded In Tissue or Plaque	58	58
Burn(s)	49	920
Unintended Radiation Exposure	28	28
Superficial (First Degree) Burn	25	545
No Information	23	133
Injury	18	18
Perforation	15	15
Hemorrhage/Bleeding	13	13
Spinal Cord Injury	10	10
Unspecified Tissue Injury	10	10
Chemical Exposure	10	10
Radiation Exposure, Unintended	8	8
Pain	7	7
Abrasion	5	5
Cerebrospinal Fluid Leakage	4	4
Numbness	4	4
Paresis	3	3
Nerve Damage	3	3
Partial thickness (Second Degree) Burn	2	7
Swelling/ Edema	2	2
Perforation of Vessels	2	2
Laceration(s)	2	2
Blood Loss	2	2
Burn, Thermal	2	41
Hematoma	2	2
Patient Problem/Medical Problem	2	2
Unspecified Infection	2	2
Oversedation	1	1
Erythema	1	1
Cerebral Hyperperfusion Syndrome	1	1
Awareness during Anaesthesia	1	1
Visual Impairment	1	1
Abscess	1	1
Bone Fracture(s)	1	1
Necrosis	1	1
No Code Available	1	1
Brain Injury	1	1
Tissue Damage	1	1
Pulmonary Dysfunction	1	1
Death	1	1
Hypoesthesia	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1