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	11	11
Insufficient Information	5	5
Product Quality Problem	3	3
Device Slipped	3	3
Patient-Device Incompatibility	2	2
Detachment of Device or Device Component	2	2
Detachment Of Device Component	2	2
Component Incompatible	2	2
Material Separation	2	2
Inadequacy of Device Shape and/or Size	1	1
Migration	1	1
Physical Resistance/Sticking	1	1
Misassembled During Installation	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
Crack	1	1
Unintended Ejection	1	1
Component Falling	1	1
Mechanical Problem	1	1
Migration or Expulsion of Device	1	1
Unintended System Motion	1	1
Device Operates Differently Than Expected	1	1
Device-Device Incompatibility	1	1
Mechanics Altered	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Component Missing	1	1
Defective Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Fall	18	18
No Clinical Signs, Symptoms or Conditions	13	13
No Consequences Or Impact To Patient	11	11
Pain	7	7
Injury	6	6
Tissue Damage	4	4
No Known Impact Or Consequence To Patient	3	3
Unspecified Tissue Injury	2	2
Limb Fracture	2	2
Joint Dislocation	2	2
Impaired Healing	2	2
Hip Fracture	2	2
Failure of Implant	2	2
Bone Fracture(s)	2	2
Bruise/Contusion	2	2
Head Injury	1	1
Hemorrhage/Bleeding	1	1
Fatigue	1	1
Unspecified Infection	1	1
Laceration(s)	1	1
Skin Irritation	1	1
Swelling	1	1
Fracture, Arm	1	1
Arthralgia	1	1
Depression	1	1
Optical Tissue, Breakdown Of	1	1
Concussion	1	1
Pressure Sores	1	1
Discomfort	1	1
Reaction	1	1
Loss of consciousness	1	1
Irritability	1	1
Tooth Fracture	1	1
Low Oxygen Saturation	1	1
Ambulation Difficulties	1	1
Osteopenia/ Osteoporosis	1	1
Vertebral Fracture	1	1
Subluxation	1	1
Blister	1	1
Insufficient Information	1	1
No Information	1	1