TPLC - Total Product Life Cycle

• Device: component, external, limb, ankle/foot
• Product Code: ISH
• Regulation Number: 890.3420
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	4	4
2020	5	5
2021	3	3
2022	2	2
2023	21	21
2024	1	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Naturally Worn	18	18
Insufficient Information	4	4
Break	4	4
Fracture	4	4
Product Quality Problem	3	3
Patient-Device Incompatibility	2	2
Detachment of Device or Device Component	2	2
Mechanics Altered	1	1
Material Separation	1	1
Mechanical Problem	1	1
Unintended System Motion	1	1
Unintended Ejection	1	1
Migration	1	1
Physical Resistance/Sticking	1	1
Misassembled During Installation	1	1
Therapeutic or Diagnostic Output Failure	1	1
Unintended Movement	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	13	13
Fall	8	8
No Consequences Or Impact To Patient	3	3
Unspecified Tissue Injury	2	2
Limb Fracture	2	2
Pain	2	2
Injury	2	2
Joint Dislocation	2	2
Reaction	1	1
Irritability	1	1
Tooth Fracture	1	1
Ambulation Difficulties	1	1
Osteopenia/ Osteoporosis	1	1
No Information	1	1
Hip Fracture	1	1
Arthralgia	1	1
Depression	1	1
Tissue Damage	1	1
Optical Tissue, Breakdown Of	1	1
Concussion	1	1
Fatigue	1	1
Bone Fracture(s)	1	1
Hemorrhage/Bleeding	1	1
Failure of Implant	1	1
Laceration(s)	1	1
Vertebral Fracture	1	1
Subluxation	1	1
Blister	1	1
Insufficient Information	1	1
Discomfort	1	1
Bruise/Contusion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ossur Americas	II	Jul-05-2022
2	Ossur H / F	II	Jun-13-2023