TPLC - Total Product Life Cycle

• Device: orthosis, corrective shoe
• Product Code: KNP
• Regulation Number: 890.3475
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	4	4
2015	6	6
2016	3	3
2017	7	7
2018	3	3
2019	20	20
2020	6	6
2021	3	3
2022	8	8
2023	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	23	23
Insufficient Information	15	15
Patient Device Interaction Problem	4	4
Break	4	4
Naturally Worn	3	3
Device Contaminated During Manufacture or Shipping	2	2
Product Quality Problem	2	2
Inadequacy of Device Shape and/or Size	1	1
Device Slipped	1	1
Device Inoperable	1	1
Unstable	1	1
Use of Device Problem	1	1
Structural Problem	1	1
Device Markings/Labelling Problem	1	1
Device Operates Differently Than Expected	1	1
Hole In Material	1	1
Inflation Problem	1	1
Loose or Intermittent Connection	1	1
Mechanical Problem	1	1
Sharp Edges	1	1
Material Distortion	1	1
Material Twisted/Bent	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pressure Sores	9	9
Unspecified Infection	6	6
Ulcer	6	6
Bone Fracture(s)	5	5
Injury	5	5
Fall	4	4
Pain	4	4
Unspecified Tissue Injury	3	3
No Known Impact Or Consequence To Patient	2	2
No Code Available	2	2
Post Traumatic Wound Infection	2	2
Therapeutic Response, Decreased	2	2
Head Injury	2	2
Headache	1	1
Sprain	1	1
Swelling	1	1
Tissue Damage	1	1
Concussion	1	1
Rupture	1	1
Infection, Direct	1	1
Laceration(s)	1	1
Myocardial Infarction	1	1
Neurological Deficit/Dysfunction	1	1
Abrasion	1	1
Erosion	1	1
Burn(s)	1	1
Erythema	1	1
Sleep Dysfunction	1	1
Physical Entrapment	1	1
Discomfort	1	1
Joint Disorder	1	1
Inadequate Pain Relief	1	1
Skin Inflammation	1	1
Post Operative Wound Infection	1	1
Thrombosis/Thrombus	1	1
Limb Fracture	1	1
Muscle/Tendon Damage	1	1
No Information	1	1
Insufficient Information	1	1