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	95	95
Mechanical Problem	82	82
Unintended System Motion	81	81
Patient Device Interaction Problem	9	9
Insufficient Information	7	7
Break	7	7
Device Operates Differently Than Expected	5	5
Patient-Device Incompatibility	4	4
Detachment of Device or Device Component	3	3
No Apparent Adverse Event	3	3
Material Twisted/Bent	2	2
Mechanical Jam	2	2
Defective Device	2	2
Collapse	2	2
Fracture	2	2
Inadequacy of Device Shape and/or Size	2	2
Use of Device Problem	2	2
Defective Component	2	2
Physical Resistance/Sticking	2	2
Device Fell	1	1
Misassembled During Installation	1	1
Appropriate Term/Code Not Available	1	1
Missing Value Reason	1	1
Component Missing	1	1
Failure to Align	1	1
Device Slipped	1	1
Unexpected Therapeutic Results	1	1
Unstable	1	1
Labelling, Instructions for Use or Training Problem	1	1
Loose or Intermittent Connection	1	1
Migration or Expulsion of Device	1	1
Detachment Of Device Component	1	1
Component Incompatible	1	1
Crack	1	1
Folded	1	1
Off-Label Use	1	1
Device Packaging Compromised	1	1
Human-Device Interface Problem	1	1
Material Deformation	1	1
Material Integrity Problem	1	1
Deformation Due to Compressive Stress	1	1
Contamination /Decontamination Problem	1	1
Unintended Movement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	82	82
Damage to Ligament(s)	68	68
Fall	13	13
Injury	13	13
Bone Fracture(s)	8	8
Pain	8	8
No Consequences Or Impact To Patient	6	6
Tissue Damage	5	5
Laceration(s)	5	5
No Known Impact Or Consequence To Patient	4	4
Insufficient Information	3	3
Patient Problem/Medical Problem	3	3
Joint Dislocation	3	3
Swelling	3	3
Abrasion	3	3
Bruise/Contusion	2	2
Hematoma	2	2
Unspecified Infection	2	2
Rash	2	2
Complaint, Ill-Defined	2	2
Cramp(s)	1	1
Impaired Healing	1	1
Skin Tears	1	1
Ambulation Difficulties	1	1
Blood Loss	1	1
Tissue Breakdown	1	1
Fluid Discharge	1	1
Thrombosis	1	1
Loss of Range of Motion	1	1
Rupture	1	1
Convulsion, Clonic	1	1
Convulsion, Tonic	1	1
Discomfort	1	1
Scarring	1	1
Skin Erosion	1	1
Skin Irritation	1	1
Sprain	1	1
Inflammation	1	1
Necrosis	1	1
Neuropathy	1	1
Hypersensitivity/Allergic reaction	1	1
Cellulitis	1	1
Edema	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hip Fracture	1	1
Peroneal Nerve Palsy	1	1
Lead(s), Burn(s) From	1	1
Thrombosis/Thrombus	1	1
Limb Fracture	1	1
Blister	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1