TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	119	119
Unintended System Motion	118	118
Adverse Event Without Identified Device or Use Problem	95	95
No Apparent Adverse Event	24	24
Patient Device Interaction Problem	9	9
Insufficient Information	7	7
Break	7	7
Patient-Device Incompatibility	5	5
Device Operates Differently Than Expected	5	5
Detachment of Device or Device Component	3	3
Fracture	2	2
Collapse	2	2
Inadequacy of Device Shape and/or Size	2	2
Mechanical Jam	2	2
Physical Resistance/Sticking	2	2
Material Twisted/Bent	2	2
Defective Component	2	2
Defective Device	2	2
Use of Device Problem	2	2
Appropriate Term/Code Not Available	1	1
Labelling, Instructions for Use or Training Problem	1	1
Missing Value Reason	1	1
Folded	1	1
Device Packaging Compromised	1	1
Failure to Align	1	1
Component Missing	1	1
Contamination /Decontamination Problem	1	1
Misassembled During Installation	1	1
Material Integrity Problem	1	1
Crack	1	1
Migration or Expulsion of Device	1	1
Off-Label Use	1	1
Detachment Of Device Component	1	1
Loose or Intermittent Connection	1	1
Deformation Due to Compressive Stress	1	1
Component Incompatible	1	1
Unexpected Therapeutic Results	1	1
Human-Device Interface Problem	1	1
Material Deformation	1	1
Unintended Movement	1	1
Device Fell	1	1
Device Slipped	1	1
Unstable	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	119	119
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
Patient Problem/Medical Problem	3	3
Joint Dislocation	3	3
Abrasion	3	3
Insufficient Information	3	3
Swelling	3	3
Unspecified Infection	2	2
Bruise/Contusion	2	2
Complaint, Ill-Defined	2	2
Hematoma	2	2
Rash	2	2
Ambulation Difficulties	1	1
Tissue Breakdown	1	1
Lead(s), Burn(s) From	1	1
Skin Tears	1	1
Swelling/ Edema	1	1
Unspecified Tissue Injury	1	1
Limb Fracture	1	1
Fluid Discharge	1	1
Peroneal Nerve Palsy	1	1
Thrombosis	1	1
Discomfort	1	1
Cramp(s)	1	1
Loss of Range of Motion	1	1
Thrombosis/Thrombus	1	1
Convulsion, Tonic	1	1
Skin Erosion	1	1
Cellulitis	1	1
Blister	1	1
Edema	1	1
Blood Loss	1	1
Rupture	1	1
Scarring	1	1
Inflammation	1	1
Sprain	1	1
Necrosis	1	1
Fungal Infection	1	1
Skin Irritation	1	1
Hip Fracture	1	1
Hypersensitivity/Allergic reaction	1	1
Convulsion, Clonic	1	1