TPLC - Total Product Life Cycle

show TPLC since

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
Device Displays Incorrect Message	4	4
Device Issue	4	4
Improper or Incorrect Procedure or Method	4	4
Device Operates Differently Than Expected	4	4
Material Separation	4	4
Material Puncture/Hole	3	3
Protective Measures Problem	3	3
Labelling, Instructions for Use or Training Problem	3	3
Material Deformation	3	3
Component Missing	3	3
Difficult to Remove	3	3
Air/Gas in Device	3	3
Malposition of Device	3	3
Fail-Safe Problem	3	3
No Device Output	2	2
Hole In Material	2	2
Deformation Due to Compressive Stress	2	2
Material Frayed	2	2
Fitting Problem	2	2
Chemical Problem	2	2
Blocked Connection	2	2
Physical Resistance	2	2
Material Fragmentation	2	2
Separation Failure	2	2
Crack	2	2
Difficult to Insert	1	1
Unraveled Material	1	1
Fail-Safe Design Failure	1	1
Use of Device Problem	1	1
Pumping Stopped	1	1
Gas/Air Leak	1	1
Material Twisted/Bent	1	1
Device Operational Issue	1	1
Device, removal of (non-implant)	1	1
Material Integrity Problem	1	1
Reflux within Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Partial Blockage	1	1
Defective Component	1	1
Migration or Expulsion of Device	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
Hematoma	5	5
Infiltration into Tissue	5	5
Phlebitis	4	4
No Code Available	3	3
Blood Loss	3	3
Multiple Organ Failure	3	3
Injury	3	3
Septic Shock	3	3
Patient Problem/Medical Problem	2	2
Low Blood Pressure/ Hypotension	2	2
Skin Irritation	2	2
Venipuncture	2	2
Foreign body, removal of	2	2
Tissue Damage	2	2
Dyspnea	2	2
Exposure to Body Fluids	2	2
Chest Pain	2	2
No Patient Involvement	2	2
Discomfort	2	2
Embolus	1	1
Respiratory Failure	1	1
Ventilator Dependent	1	1
Thromboembolism	1	1
Breathing difficulties	1	1
Headache	1	1
Underdose	1	1
Hypoxia	1	1
Tachycardia	1	1
Ecchymosis	1	1
Swelling	1	1
Loss Of Pulse	1	1
Irritation	1	1
Intracranial Hemorrhage	1	1
Aortic Dissection	1	1
Staphylococcus Aureus	1	1
Neurological Deficit/Dysfunction	1	1
Cardiac Arrest	1	1
Pericardial Effusion	1	1
Obstruction/Occlusion	1	1