TPLC - Total Product Life Cycle

show TPLC since

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Naturally Worn	18	18
Fracture	12	12
Break	9	9
Insufficient Information	5	5
Product Quality Problem	3	3
Patient-Device Incompatibility	2	2
Detachment of Device or Device Component	2	2
Device Operates Differently Than Expected	1	1
Device-Device Incompatibility	1	1
Mechanics Altered	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Torn Material	1	1
Unintended Movement	1	1
Material Separation	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Slipped	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Component Missing	1	1
Mechanical Problem	1	1
Migration or Expulsion of Device	1	1
Unintended System Motion	1	1
Migration	1	1
Physical Resistance/Sticking	1	1
Misassembled During Installation	1	1
Crack	1	1
Unintended Ejection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Fall	14	14
No Clinical Signs, Symptoms or Conditions	13	13
No Consequences Or Impact To Patient	10	10
Pain	6	6
Injury	5	5
Tissue Damage	4	4
Hip Fracture	2	2
Failure of Implant	2	2
Bone Fracture(s)	2	2
Unspecified Tissue Injury	2	2
Limb Fracture	2	2
Joint Dislocation	2	2
Impaired Healing	2	2
Reaction	1	1
Irritability	1	1
Tooth Fracture	1	1
Low Oxygen Saturation	1	1
Ambulation Difficulties	1	1
Osteopenia/ Osteoporosis	1	1
No Known Impact Or Consequence To Patient	1	1
No Information	1	1
Vertebral Fracture	1	1
Subluxation	1	1
Blister	1	1
Insufficient Information	1	1
Bruise/Contusion	1	1
Hemorrhage/Bleeding	1	1
Fatigue	1	1
Unspecified Infection	1	1
Laceration(s)	1	1
Skin Irritation	1	1
Swelling	1	1
Arthralgia	1	1
Depression	1	1
Optical Tissue, Breakdown Of	1	1
Concussion	1	1
Pressure Sores	1	1
Discomfort	1	1