TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	62	62
Activation, Positioning or Separation Problem	43	43
Positioning Failure	28	28
Adverse Event Without Identified Device or Use Problem	23	23
Fluid/Blood Leak	21	21
Insufficient Information	16	16
Detachment of Device or Device Component	10	10
Positioning Problem	10	10
Leak/Splash	6	6
Fracture	5	5
Material Separation	4	4
Device Issue	4	4
Improper or Incorrect Procedure or Method	4	4
Device Displays Incorrect Message	4	4
Device Operates Differently Than Expected	4	4
Malposition of Device	3	3
Protective Measures Problem	3	3
Labelling, Instructions for Use or Training Problem	3	3
Difficult to Remove	3	3
Air/Gas in Device	3	3
Material Deformation	3	3
Fail-Safe Problem	3	3
Material Puncture/Hole	3	3
Component Missing	3	3
Deformation Due to Compressive Stress	2	2
Physical Resistance	2	2
Crack	2	2
Blocked Connection	2	2
Separation Failure	2	2
Material Fragmentation	2	2
Material Frayed	2	2
Chemical Problem	2	2
Fitting Problem	2	2
Hole In Material	2	2
No Device Output	2	2
Kinked	1	1
Complete Blockage	1	1
Wire(s), breakage of	1	1
Torn Material	1	1
Defective Component	1	1
Material Integrity Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Uncoiled	1	1
Other (for use when an appropriate device code cannot be identified)	1	1
Tear, Rip or Hole in Device Packaging	1	1
Partial Blockage	1	1
Inadequacy of Device Shape and/or Size	1	1
Detachment Of Device Component	1	1
Loose or Intermittent Connection	1	1
No Flow	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	50	50
No Clinical Signs, Symptoms or Conditions	34	34
Device Embedded In Tissue or Plaque	28	28
No Known Impact Or Consequence To Patient	26	26
Hemorrhage/Bleeding	23	23
Needle Stick/Puncture	23	23
No Information	16	16
Foreign Body In Patient	16	16
Death	8	8
Pneumothorax	7	7
Insufficient Information	7	7
Infiltration into Tissue	5	5
Hematoma	5	5
Phlebitis	4	4
No Code Available	3	3
Blood Loss	3	3
Septic Shock	3	3
Multiple Organ Failure	3	3
Injury	3	3
Low Blood Pressure/ Hypotension	2	2
Tissue Damage	2	2
Dyspnea	2	2
Discomfort	2	2
Chest Pain	2	2
Exposure to Body Fluids	2	2
No Patient Involvement	2	2
Foreign body, removal of	2	2
Skin Irritation	2	2
Venipuncture	2	2
Patient Problem/Medical Problem	2	2
Aortic Dissection	1	1
Neurological Deficit/Dysfunction	1	1
Cardiac Arrest	1	1
Staphylococcus Aureus	1	1
Obstruction/Occlusion	1	1
Irritation	1	1
Pericardial Effusion	1	1
Loss Of Pulse	1	1
Intracranial Hemorrhage	1	1
Swelling	1	1
Purulent Discharge	1	1
Other (for use when an appropriate patient code cannot be identified)	1	1
Exsanguination	1	1
Hematuria	1	1
Ecchymosis	1	1
Hemolysis	1	1
Tachycardia	1	1
Respiratory Distress	1	1
Underdose	1	1
Hypoxia	1	1