TPLC - Total Product Life Cycle

• Device: crutch
• Product Code: IPR
• Regulation Number: 890.3150
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2014	53	53
2015	12	12
2016	9	9
2017	4	4
2018	4	4
2019	4	4
2020	5	5
2021	3	3
2022	4	4
2023	7	7
2024	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	42	42
Unstable	10	10
Collapse	5	5
Product Quality Problem	5	5
Detachment Of Device Component	5	5
Device Slipped	3	3
Material Disintegration	3	3
Disassembly	3	3
Bent	3	3
Fracture	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Loose or Intermittent Connection	3	3
Device Fell	2	2
Detachment of Device or Device Component	2	2
Torn Material	2	2
Crack	2	2
Split	2	2
Material Integrity Problem	2	2
Appropriate Term/Code Not Available	2	2
Device Operates Differently Than Expected	2	2
Naturally Worn	2	2
Material Frayed	1	1
Material Split, Cut or Torn	1	1
Insufficient Information	1	1
Material Separation	1	1
Component Falling	1	1
Defective Device	1	1
Defective Component	1	1
Material Deformation	1	1
Degraded	1	1
Material Twisted/Bent	1	1
Out-Of-Box Failure	1	1
Device Issue	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	40	40
Fall	29	29
Injury	12	12
No Clinical Signs, Symptoms or Conditions	5	5
Discomfort	4	4
Laceration(s)	4	4
Bone Fracture(s)	3	3
Damage to Ligament(s)	2	2
No Known Impact Or Consequence To Patient	2	2
Insufficient Information	2	2
Pain	2	2
Skin Tears	2	2
Sleep Dysfunction	1	1
No Code Available	1	1
Disability	1	1
Head Injury	1	1
Abrasion	1	1
Contusion	1	1
No Patient Involvement	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	1	1
Loss of consciousness	1	1