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 Operates Differently Than Expected	4	4
Device Issue	4	4
Device Displays Incorrect Message	4	4
Improper or Incorrect Procedure or Method	4	4
Material Separation	4	4
Protective Measures Problem	3	3
Malposition of Device	3	3
Fail-Safe Problem	3	3
Air/Gas in Device	3	3
Difficult to Remove	3	3
Material Puncture/Hole	3	3
Labelling, Instructions for Use or Training Problem	3	3
Material Deformation	3	3
Component Missing	3	3
Hole In Material	2	2
No Device Output	2	2
Physical Resistance	2	2
Blocked Connection	2	2
Material Fragmentation	2	2
Deformation Due to Compressive Stress	2	2
Fitting Problem	2	2
Material Frayed	2	2
Chemical Problem	2	2
Separation Failure	2	2
Crack	2	2
Uncoiled	1	1
Material Split, Cut or Torn	1	1
Detachment Of Device Component	1	1
Device Inoperable	1	1
Image Orientation Incorrect	1	1
Connection Problem	1	1
Maintenance Does Not Comply To Manufacturers Recommendations	1	1
Failure to Advance	1	1
Device Contaminated During Manufacture or Shipping	1	1
Disconnection	1	1
Device, removal of (non-implant)	1	1
Separation Problem	1	1
Migration or Expulsion of Device	1	1
Reflux within Device	1	1
Unraveled Material	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