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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device posterior ratcheting rod system
Definition Stabilization or correction of adolescent idiopathic scoliosis without the use of fusion.
Product CodeQGP
Device Class Not Classified

MDR Year MDR Reports MDR Events
2020 21 21
2021 47 47
2022 68 68
2023 70 70
2024 67 67
2025 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 58 58
Break 54 54
No Apparent Adverse Event 49 49
Fracture 37 37
Unintended Movement 36 36
Migration 20 20
Noise, Audible 17 17
Appropriate Term/Code Not Available 16 16
Improper or Incorrect Procedure or Method 15 15
Off-Label Use 9 9
Patient-Device Incompatibility 7 7
Insufficient Information 6 6
Loosening of Implant Not Related to Bone-Ingrowth 5 5
Mechanical Problem 4 4
Failure to Align 3 3
Device Dislodged or Dislocated 3 3
Loss of Osseointegration 3 3
Use of Device Problem 2 2
Detachment of Device or Device Component 2 2
Inaccurate Information 2 2
Biocompatibility 2 2
Overcorrection 1 1
Collapse 1 1
Degraded 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 117 117
Failure of Implant 68 68
Pain 56 56
Implant Pain 20 20
Physical Asymmetry 19 19
Insufficient Information 18 18
Unspecified Infection 9 9
Discomfort 8 8
Therapeutic Response, Decreased 6 6
Post Operative Wound Infection 5 5
Bacterial Infection 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Wound Dehiscence 3 3
Osteolysis 2 2
Unspecified Tissue Injury 2 2
Metal Related Pathology 1 1
Paresthesia 1 1
Cerebrospinal Fluid Leakage 1 1
Fistula 1 1

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