TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1058	1058
Degraded	160	160
Material Deformation	159	159
Material Separation	152	152
Material Twisted/Bent	129	129
Detachment of Device or Device Component	127	127
Difficult to Open or Close	115	115
Mechanical Jam	110	110
Device Contaminated During Manufacture or Shipping	64	64
Device-Device Incompatibility	49	49
Material Fragmentation	41	41
Fracture	39	39
Dull, Blunt	39	39
Adverse Event Without Identified Device or Use Problem	30	30
Use of Device Problem	24	24
Corroded	24	24
Device Damaged by Another Device	23	23
Flaked	22	22
Device Contamination with Chemical or Other Material	21	21
Physical Resistance/Sticking	21	21
Appropriate Term/Code Not Available	20	20
Crack	18	18
Defective Device	17	17
Failure to Cut	16	16
Component Missing	16	16
Mechanical Problem	15	15
Insufficient Information	15	15
Contamination /Decontamination Problem	14	14
Leak/Splash	11	11
Material Integrity Problem	11	11
Material Split, Cut or Torn	10	10
Fluid/Blood Leak	10	10
Device Markings/Labelling Problem	10	10
Failure to Advance	9	9
Device Dislodged or Dislocated	9	9
Loose or Intermittent Connection	8	8
Entrapment of Device	7	7
Delivered as Unsterile Product	7	7
Difficult to Remove	7	7
Sharp Edges	7	7
Scratched Material	6	6
Packaging Problem	6	6
Illegible Information	5	5
Firing Problem	5	5
Material Discolored	5	5
Failure to Align	5	5
Connection Problem	5	5
Device Damaged Prior to Use	5	5
Problem with Sterilization	4	4
Contamination	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1618	1618
No Known Impact Or Consequence To Patient	226	226
No Consequences Or Impact To Patient	218	218
Insufficient Information	139	139
Foreign Body In Patient	127	127
No Information	47	47
Not Applicable	32	32
No Patient Involvement	32	32
Device Embedded In Tissue or Plaque	30	30
No Code Available	17	17
Pain	14	14
Injury	13	13
Tissue Damage	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Failure of Implant	5	5
Laceration(s)	5	5
Perforation	4	4
Unspecified Tissue Injury	4	4
Rupture	3	3
Extravasation	3	3
Swelling/ Edema	3	3
Hypersensitivity/Allergic reaction	2	2
Scar Tissue	2	2
Neuropathy	1	1
Patient Problem/Medical Problem	1	1
Sepsis	1	1
Inadequate Osseointegration	1	1
Unspecified Musculoskeletal problem	1	1
Itching Sensation	1	1
Post Operative Wound Infection	1	1
Paresthesia	1	1
Burning Sensation	1	1
Needle Stick/Puncture	1	1
Exposure to Body Fluids	1	1
Nerve Damage	1	1
Loss of Range of Motion	1	1
Numbness	1	1
Capsular Contracture	1	1