TPLC - Total Product Life Cycle

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Device	joint, knee, external limb component
Regulation Description	External limb prosthetic component.
Product Code	ISY
Regulation Number	890.3420
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended System Motion	62	62
Mechanical Problem	32	32
Insufficient Information	23	23
Physical Resistance/Sticking	18	18
Unintended Movement	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Fracture	2	2
Premature Discharge of Battery	2	2
Leak/Splash	1	1
Patient Device Interaction Problem	1	1
Misassembled During Installation	1	1
Battery Problem	1	1
Material Deformation	1	1
Material Separation	1	1
Electromagnetic Interference	1	1
Connection Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Intermittent Loss of Power	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Fall	92	92
Limb Fracture	36	36
No Clinical Signs, Symptoms or Conditions	33	33
Bone Fracture(s)	18	18
Hip Fracture	12	12
Insufficient Information	12	12
Bruise/Contusion	11	11
Laceration(s)	8	8
Damage to Ligament(s)	5	5
Spinal Column Injury	4	4
Pain	4	4
Multiple Fractures	3	3
Concussion	3	3
Abrasion	2	2
Muscle/Tendon Damage	2	2
Tissue Breakdown	2	2
Skin Infection	1	1
Arthralgia	1	1
Inadequate Osseointegration	1	1
Skull Fracture	1	1
Head Injury	1	1
Post Operative Wound Infection	1	1
Nerve Damage	1	1
Intervertebral Disc Compression or Protrusion	1	1