TPLC - Total Product Life Cycle

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Device	assembly, knee/shank/ankle/foot, external
Product Code	ISW
Regulation Number	890.3500
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Operates Differently Than Expected	13	13
Adverse Event Without Identified Device or Use Problem	8	8
Insufficient Information	4	4
Break	3	3
Fracture	3	3
Loose or Intermittent Connection	3	3
Solder Joint Fracture	2	2
Deformation Due to Compressive Stress	2	2
Electrical /Electronic Property Problem	2	2
Physical Resistance/Sticking	1	1
Output Problem	1	1
Positioning Problem	1	1
Protective Measures Problem	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Defective Device	1	1
Battery Problem	1	1
Human Factors Issue	1	1
Inadequate User Interface	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Protrusion/Extrusion	1	1
Material Twisted/Bent	1	1
Mechanical Problem	1	1
Inadequate Service	1	1
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Material Fragmentation	1	1
Failure to Charge	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Fall	29	29
No Consequences Or Impact To Patient	11	11
Bone Fracture(s)	9	9
Bruise/Contusion	4	4
Injury	3	3
Hip Fracture	3	3
No Known Impact Or Consequence To Patient	2	2
Rupture	2	2
Head Injury	2	2
Failure of Implant	1	1
Laceration(s)	1	1
Damage to Ligament(s)	1	1
Pain	1	1
Pneumonia	1	1
Concussion	1	1
Contusion	1	1
Death	1	1
Limb Fracture	1	1
Unspecified Tissue Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ability Dynamics LLC	II	Jun-18-2014
2	Ossur Americas	II	Sep-28-2022
3	Ossur H / F	II	Jan-25-2024
4	Ossur H / F	II	Mar-25-2015
5	Otto Bock Healthcare Product	II	Aug-21-2015
6	iwalk inc	II	Dec-04-2012