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
2020	22	22
2021	4	4
2022	5	5
2023	75	75
2024	110	110
2025	30	30

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	210	210
Unintended System Motion	210	210
No Apparent Adverse Event	116	116
Adverse Event Without Identified Device or Use Problem	21	21
Insufficient Information	2	2
Defective Device	2	2
Fracture	2	2
Device Slipped	1	1
Break	1	1
Physical Resistance/Sticking	1	1
Crack	1	1
Patient-Device Incompatibility	1	1
Unintended Movement	1	1
Defective Component	1	1
Material Integrity Problem	1	1
Patient Device Interaction Problem	1	1
Misassembled During Installation	1	1
Failure to Align	1	1
Detachment of Device or Device Component	1	1
Unexpected Therapeutic Results	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	212	212
Damage to Ligament(s)	16	16
Fall	5	5
Insufficient Information	3	3
Patient Problem/Medical Problem	2	2
Laceration(s)	2	2
Pain	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Hypersensitivity/Allergic reaction	1	1
Hip Fracture	1	1
Hematoma	1	1
Blister	1	1
Injury	1	1
Thrombosis/Thrombus	1	1
Limb Fracture	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Skin Tears	1	1
No Consequences Or Impact To Patient	1	1
Ambulation Difficulties	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mueller Sports Medicine, Inc	II	Jun-30-2020