TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2016	13	13
2017	8	8
2018	12	12
2019	8	8
2020	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	17	17
Insufficient Information	5	5
Patient Device Interaction Problem	3	3
Fracture	3	3
Inadequacy of Device Shape and/or Size	3	3
Unstable	2	2
Malposition of Device	2	2
Use of Device Problem	2	2
Device Operates Differently Than Expected	2	2
Naturally Worn	1	1
Patient-Device Incompatibility	1	1
Material Separation	1	1
Loss of or Failure to Bond	1	1
Break	1	1
Collapse	1	1
Crack	1	1
Improper or Incorrect Procedure or Method	1	1
Unintended Movement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pressure Sores	7	7
Bruise/Contusion	4	4
Tissue Damage	4	4
Injury	2	2
Damage to Ligament(s)	2	2
Tissue Breakdown	2	2
Patient Problem/Medical Problem	2	2
No Information	2	2
Reaction	2	2
Sprain	2	2
Swelling	2	2
Thrombosis	2	2
No Consequences Or Impact To Patient	1	1
Ulcer	1	1
Fall	1	1
Fungus	1	1
Rash	1	1
Skin Discoloration	1	1
Skin Irritation	1	1
No Known Impact Or Consequence To Patient	1	1
Post Operative Wound Infection	1	1
No Code Available	1	1
Pain	1	1
Scarring	1	1
Impaired Healing	1	1
Bone Fracture(s)	1	1
Hemorrhage/Bleeding	1	1
Unspecified Infection	1	1
Laceration(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ossur H / F	II	Mar-31-2016