TPLC - Total Product Life Cycle

• Device: joint, knee, external brace
• Regulation Description: Limb orthosis.
• Product Code: ITQ
• Regulation Number: 890.3475
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2021	4	7
2022	5	5
2023	75	75
2024	110	110
2025	45	45
2026	7	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	222	222
Unintended System Motion	221	221
No Apparent Adverse Event	125	125
Adverse Event Without Identified Device or Use Problem	5	5
Material Split, Cut or Torn	3	3
Physical Resistance/Sticking	2	2
Insufficient Information	2	2
Defective Device	2	4
Patient Device Interaction Problem	2	2
Device Slipped	1	3
Activation, Positioning or Separation Problem	1	1
Break	1	2
Patient-Device Incompatibility	1	1
Unintended Movement	1	1
Defective Component	1	1
Misassembled During Installation	1	1
Degraded	1	1
Failure to Align	1	1
Material Twisted/Bent	1	1
Detachment of Device or Device Component	1	3
Material Protrusion/Extrusion	1	1
Fracture	1	1
Unexpected Therapeutic Results	1	1
Loose or Intermittent Connection	1	3
Loss of or Failure to Bond	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	227	227
Insufficient Information	6	8
Fall	5	5
Pain	3	3
Hip Fracture	2	2
Laceration(s)	2	2
Damage to Ligament(s)	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Brain Injury	1	1
Bone Fracture(s)	1	1
Head Injury	1	1
Hematoma	1	1
Abrasion	1	1
Blister	1	1
Thrombosis/Thrombus	1	1
Concussion	1	1
Limb Fracture	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Skin Tears	1	1
Bruise/Contusion	1	1
Ambulation Difficulties	1	2