TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	228	229
Insufficient Information	48	48
Material Puncture/Hole	17	17
Fluid/Blood Leak	13	13
Lack of Effect	12	12
Material Disintegration	9	9
Degraded	8	8
Patient Device Interaction Problem	8	8
Failure to Seal	7	7
Nonstandard Device	6	6
Break	5	5
Material Split, Cut or Torn	4	4
Material Separation	4	4
Material Integrity Problem	4	4
Material Rupture	3	3
Naturally Worn	2	2
Device Appears to Trigger Rejection	2	2
Appropriate Term/Code Not Available	2	2
Material Deformation	2	2
Adhesive Too Strong	2	2
Microbial Contamination of Device	2	2
Material Erosion	2	2
Device Contaminated During Manufacture or Shipping	2	2
Compatibility Problem	2	2
Difficult to Remove	1	1
Contamination /Decontamination Problem	1	1
Contamination	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Therapeutic or Diagnostic Output Failure	1	1
Expiration Date Error	1	1
Material Perforation	1	1
Patient-Device Incompatibility	1	1
Delivered as Unsterile Product	1	1
Device Markings/Labelling Problem	1	1
Device Damaged Prior to Use	1	1
Misassembly by Users	1	1
Device Handling Problem	1	1
Product Quality Problem	1	1
Off-Label Use	1	1
No Apparent Adverse Event	1	1
Fracture	1	1
Device Dislodged or Dislocated	1	1
Mechanical Problem	1	1
Gel Leak	1	1
Expulsion	1	1
Calcified	1	1
Loose or Intermittent Connection	1	1
Fitting Problem	1	1
Biocompatibility	1	1
Leak/Splash	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cerebrospinal Fluid Leakage	152	153
Unspecified Infection	42	42
Meningitis	37	38
Headache	31	31
No Clinical Signs, Symptoms or Conditions	21	21
Failure of Implant	20	20
Bacterial Infection	19	19
Insufficient Information	16	16
Post Operative Wound Infection	16	16
Swelling/ Edema	14	14
Fever	14	14
Hematoma	13	14
Hydrocephalus	12	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Abscess	11	11
Hypersensitivity/Allergic reaction	10	10
Foreign Body Reaction	9	9
Cerebral Edema	8	8
Pain	8	8
Fistula	7	8
Hemorrhage/Bleeding	7	7
Unspecified Tissue Injury	7	8
Adhesion(s)	7	7
Fungal Infection	5	5
Cyst(s)	5	5
Inflammation	5	5
Purulent Discharge	5	5
Sepsis	4	4
Low Blood Pressure/ Hypotension	3	3
Cancer	3	3
Discomfort	3	3
Paralysis	3	3
Local Reaction	3	3
Impaired Healing	3	3
Fatigue	3	3
Emotional Changes	3	3
Implant Pain	2	2
Cramp(s) /Muscle Spasm(s)	2	2
Unspecified Nervous System Problem	2	2
Wound Dehiscence	2	2
Convulsion/Seizure	2	2
Speech Disorder	2	2
Nausea	2	2
Numbness	2	2
Anaphylactic Shock	2	2
Fluid Discharge	2	2
Bradycardia	2	2
Hearing Impairment	1	1
Ambulation Difficulties	1	1
High Blood Pressure/ Hypertension	1	1