TPLC - Total Product Life Cycle

• Device: pedicle screw spinal system, adolescent idiopathic scoliosis
• Definition: Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
• Product Code: OSH
• Regulation Number: 888.3070
• Device Class: 2

MDR Year	MDR Reports	MDR Events
2019	12	12
2020	12	12
2021	2	2
2022	8	8
2023	19	19
2024	12	12

Device Problems	MDRs with this Device Problem	Events in those MDRs
Migration	14	14
Fracture	14	14
Break	9	9
Material Twisted/Bent	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Device Slipped	3	3
Material Integrity Problem	3	3
Detachment of Device or Device Component	2	2
Naturally Worn	2	2
Insufficient Information	1	1
Therapeutic or Diagnostic Output Failure	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Use of Device Problem	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	13	13
Insufficient Information	9	9
Failure of Implant	8	8
No Information	8	8
Pain	8	8
No Known Impact Or Consequence To Patient	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Implant Pain	4	4
Unspecified Infection	3	3
Nerve Damage	2	2
Osteolysis	2	2
Joint Laxity	2	2
No Consequences Or Impact To Patient	2	2
Emotional Changes	1	1
Bone Fracture(s)	1	1
Spinal Column Injury	1	1
Depression	1	1
Anxiety	1	1
Non-union Bone Fracture	1	1
Device Embedded In Tissue or Plaque	1	1