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	246	246
Insufficient Information	42	42
Product Quality Problem	13	13
Fluid/Blood Leak	12	12
Material Disintegration	10	10
Material Puncture/Hole	10	10
Patient Device Interaction Problem	9	9
Lack of Effect	8	8
Material Split, Cut or Torn	7	7
Nonstandard Device	7	7
Material Integrity Problem	7	7
Degraded	7	7
Appropriate Term/Code Not Available	6	6
Improper or Incorrect Procedure or Method	5	5
Device Appears to Trigger Rejection	5	5
Compatibility Problem	4	4
Break	4	4
Material Rupture	4	4
Device Markings/Labelling Problem	3	3
Gel Leak	3	3
Material Separation	3	3
Device Contaminated During Manufacture or Shipping	2	2
Naturally Worn	2	2
Material Erosion	2	2
Defective Device	2	2
Microbial Contamination of Device	2	2
Failure to Seal	1	1
Biocompatibility	1	1
Loose or Intermittent Connection	1	1
Calcified	1	1
Device Dislodged or Dislocated	1	1
Fracture	1	1
No Apparent Adverse Event	1	1
Misassembly by Users	1	1
Delivered as Unsterile Product	1	1
Material Twisted/Bent	1	1
Component Missing	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Contamination /Decontamination Problem	1	1
Difficult to Remove	1	1
Expiration Date Error	1	1
Defective Component	1	1
Patient-Device Incompatibility	1	1
Device Damaged Prior to Use	1	1
Physical Resistance/Sticking	1	1
Migration or Expulsion of Device	1	1
Mechanical Problem	1	1
Expulsion	1	1
Fitting Problem	1	1
Leak/Splash	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Cerebrospinal Fluid Leakage	163	163
Unspecified Infection	51	51
Meningitis	35	35
Headache	24	24
Fever	20	20
Injury	19	19
No Clinical Signs, Symptoms or Conditions	18	18
Failure of Implant	15	15
Bacterial Infection	15	15
Post Operative Wound Infection	14	14
Hydrocephalus	13	13
Hematoma	13	13
Swelling/ Edema	12	12
Hypersensitivity/Allergic reaction	11	11
Inflammation	11	11
Pain	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Adhesion(s)	10	10
Fistula	9	9
Insufficient Information	9	9
Abscess	8	8
Hemorrhage/Bleeding	8	8
Foreign Body Reaction	8	8
Unspecified Tissue Injury	7	7
Wound Dehiscence	5	5
Cerebral Edema	4	4
Numbness	4	4
Seizures	4	4
Sepsis	4	4
Cyst(s)	4	4
Edema	4	4
Discomfort	3	3
Swelling	3	3
Muscle Spasm(s)	3	3
Seroma	3	3
No Known Impact Or Consequence To Patient	3	3
Local Reaction	3	3
Purulent Discharge	3	3
Muscle Weakness	3	3
Emotional Changes	3	3
Cancer	3	3
Patient Problem/Medical Problem	3	3
Impaired Healing	3	3
Cramp(s) /Muscle Spasm(s)	2	2
Necrosis	2	2
Unspecified Nervous System Problem	2	2
Nausea	2	2
Paralysis	2	2
Stenosis	2	2
Anaphylactic Shock	2	2