TPLC - Total Product Life Cycle

• Device: walker, mechanical
• Product Code: ITJ
• Regulation Number: 890.3825
• Device Class: 1

MDR Year	MDR Reports	MDR Events
2019	114	114
2020	117	117
2021	81	81
2022	114	114
2023	140	140
2024	17	17

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	121	121
Adverse Event Without Identified Device or Use Problem	61	61
Fracture	51	51
Appropriate Term/Code Not Available	31	31
Insufficient Information	28	28
Use of Device Problem	27	27
Detachment of Device or Device Component	26	26
Mechanical Problem	25	25
Unintended Movement	25	25
Material Integrity Problem	23	23
Material Fragmentation	23	23
Collapse	23	23
Material Twisted/Bent	19	19
Solder Joint Fracture	15	15
Sharp Edges	12	12
Device Slipped	11	11
Defective Component	7	7
Improper or Incorrect Procedure or Method	6	6
Crack	6	6
Material Separation	6	6
Device Fell	5	5
Device Dislodged or Dislocated	5	5
Patient Device Interaction Problem	4	4
Device Damaged Prior to Use	4	4
Component Missing	4	4
Device Tipped Over	4	4
Failure to Align	4	4
Loose or Intermittent Connection	4	4
Defective Device	3	3
Unstable	3	3
Unintended System Motion	3	3
Off-Label Use	3	3
Human-Device Interface Problem	3	3
Device Unsafe to Use in Environment	3	3
Manufacturing, Packaging or Shipping Problem	2	2
Material Deformation	2	2
Mechanical Jam	2	2
Material Protrusion/Extrusion	2	2
Protective Measures Problem	2	2
No Apparent Adverse Event	2	2
Device Handling Problem	2	2
Misassembled During Installation	2	2
Product Quality Problem	2	2
Unintended Collision	2	2
Inadequacy of Device Shape and/or Size	1	1
Self-Activation or Keying	1	1
Degraded	1	1
Material Frayed	1	1
Labelling, Instructions for Use or Training Problem	1	1
Structural Problem	1	1
Failure to Advance	1	1
Patient-Device Incompatibility	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Physical Resistance/Sticking	1	1
Separation Problem	1	1
Misassembly by Users	1	1
Naturally Worn	1	1
Difficult to Open or Close	1	1
Inadequate User Interface	1	1
Lack of Maintenance Documentation or Guidelines	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Fall	252	252
Bone Fracture(s)	103	103
Laceration(s)	95	95
Bruise/Contusion	48	48
Head Injury	43	43
No Clinical Signs, Symptoms or Conditions	33	33
Pain	24	24
Insufficient Information	23	23
Hip Fracture	18	18
Limb Fracture	13	13
Injury	12	12
Concussion	11	11
No Known Impact Or Consequence To Patient	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Easy Bruising	10	10
Vertebral Fracture	7	7
Fracture, Arm	7	7
Joint Dislocation	7	7
Damage to Ligament(s)	7	7
Neck Pain	6	6
Abrasion	6	6
No Consequences Or Impact To Patient	5	5
Muscle/Tendon Damage	5	5
Swelling/ Edema	5	5
Skin Tears	4	4
Unspecified Tissue Injury	3	3
Brain Injury	3	3
Hematoma	3	3
Hemorrhage/Bleeding	2	2
Headache	2	2
Contusion	2	2
Spinal Column Injury	2	2
Multiple Fractures	2	2
No Patient Involvement	2	2
No Code Available	2	2
Tooth Fracture	2	2
Patient Problem/Medical Problem	2	2
Balance Problems	1	1
Foreign Body In Patient	1	1
Ambulation Difficulties	1	1
Cognitive Changes	1	1
Skin Infection	1	1
Drug Resistant Bacterial Infection	1	1
Strangulation	1	1
Vertigo	1	1
Loss of Vision	1	1
Physical Entrapment	1	1
Non-union Bone Fracture	1	1
Sweating	1	1
Post Traumatic Wound Infection	1	1
Loss of consciousness	1	1
Death	1	1
Erythema	1	1
Eye Injury	1	1
Hemorrhage, Cerebral	1	1
Chest Pain	1	1
Memory Loss/Impairment	1	1
Loss of Range of Motion	1	1
Scar Tissue	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Breg Inc	II	Nov-03-2023
2	Compass Health Brands (Corporate Office)	II	Jan-19-2022
3	Invacare Corporation	II	Aug-23-2023
4	James Leckey Design Ltd	II	May-27-2021
5	Nova Ortho-Med Inc	II	Dec-21-2020
6	R82 A/S	II	May-04-2020