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
Positioning Problem	10	10
Detachment of Device or Device Component	10	10
Leak/Splash	6	6
Fracture	5	5
Device Issue	4	4
Device Displays Incorrect Message	4	4
Improper or Incorrect Procedure or Method	4	4
Device Operates Differently Than Expected	4	4
Material Separation	4	4
Difficult to Remove	3	3
Air/Gas in Device	3	3
Material Puncture/Hole	3	3
Malposition of Device	3	3
Material Deformation	3	3
Fail-Safe Problem	3	3
Protective Measures Problem	3	3
Component Missing	3	3
Labelling, Instructions for Use or Training Problem	3	3
Deformation Due to Compressive Stress	2	2
Physical Resistance	2	2
Blocked Connection	2	2
Material Fragmentation	2	2
No Device Output	2	2
Hole In Material	2	2
Fitting Problem	2	2
Chemical Problem	2	2
Material Frayed	2	2
Crack	2	2
Separation Failure	2	2
No Flow	1	1
Disconnection	1	1
Loose or Intermittent Connection	1	1
Material Split, Cut or Torn	1	1
Separation Problem	1	1
Device, removal of (non-implant)	1	1
Device Contaminated During Manufacture or Shipping	1	1
Pumping Stopped	1	1
Torn Material	1	1
Output Problem	1	1
Migration or Expulsion of Device	1	1
Reflux within Device	1	1
Device Operational Issue	1	1
Kinked	1	1
Complete Blockage	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