TPLC - Total Product Life Cycle

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Device	joint, knee, external limb component
Product Code	ISY
Regulation Number	890.3420
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Mechanical Problem	164	164
Device Operates Differently Than Expected	65	65
Unintended System Motion	41	41
Device Handling Problem	40	40
Adverse Event Without Identified Device or Use Problem	22	22
Insufficient Information	16	16
Physical Resistance/Sticking	11	11
Loose or Intermittent Connection	8	8
Device Slipped	7	7
Break	5	5
Component Missing	4	4
Fracture	2	2
Crack	2	2
Improper or Incorrect Procedure or Method	2	2
Failure To Service	2	2
Device Fell	1	1
Patient Device Interaction Problem	1	1
Misassembled During Installation	1	1
Contamination /Decontamination Problem	1	1
Human Factors Issue	1	1
Stretched	1	1
Mechanics Altered	1	1
Moisture or Humidity Problem	1	1
Appropriate Term/Code Not Available	1	1
Leak/Splash	1	1
Disconnection	1	1
Positioning Problem	1	1
Bent	1	1
Material Deformation	1	1
Human-Device Interface Problem	1	1
Fungus in Device Environment	1	1
Electromagnetic Interference	1	1
Deformation Due to Compressive Stress	1	1
Electrical /Electronic Property Problem	1	1
Mechanical Jam	1	1
Component Falling	1	1
Material Twisted/Bent	1	1
Device Maintenance Issue	1	1
Use of Device Problem	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	132	132
Fall	125	125
Bone Fracture(s)	52	52
No Clinical Signs, Symptoms or Conditions	35	35
No Known Impact Or Consequence To Patient	32	32
Limb Fracture	24	24
Hip Fracture	18	18
Injury	18	18
Fracture, Arm	14	14
Bruise/Contusion	14	14
Concussion	10	10
Damage to Ligament(s)	8	8
Head Injury	8	8
Insufficient Information	8	8
Laceration(s)	8	8
Rupture	6	6
Spinal Column Injury	5	5
Joint Dislocation	3	3
Hematoma	3	3
Contusion	3	3
Pain	3	3
No Code Available	2	2
Skull Fracture	2	2
Multiple Fractures	2	2
Abrasion	2	2
Neck Pain	2	2
Tissue Breakdown	1	1
Spinal Cord Injury	1	1
Loss of consciousness	1	1
Hemorrhage/Bleeding	1	1
Intervertebral Disc Compression or Protrusion	1	1
Tissue Damage	1	1
Muscle/Tendon Damage	1	1
Physical Entrapment	1	1
No Patient Involvement	1	1
Intracranial Hemorrhage	1	1
Tooth Fracture	1	1
Crushing Injury	1	1
Arthralgia	1	1
Death	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Bock,Otto,Orthopedic Ind,Inc	II	Dec-16-2009
2	Ossur Engineering, Inc	II	Mar-25-2011
3	Ossur H / F	II	Feb-06-2012
4	Otto Bock Healthcare GmbH	II	Feb-01-2016
5	Otto Bock Healthcare GmbH	II	Jul-24-2015
6	Otto Bock Healthcare Product	II	Mar-01-2018
7	Ottobock Orthopedic Industrie	II	Feb-13-2019