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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 41 41

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 53 53
Break 48 48
No Apparent Adverse Event 25 25
Fracture 23 23
Unintended Movement 22 22
Migration 20 20
Appropriate Term/Code Not Available 16 16
Improper or Incorrect Procedure or Method 15 15
Noise, Audible 15 15
Off-Label Use 8 8
Patient-Device Incompatibility 7 7
Insufficient Information 4 4
Mechanical Problem 4 4
Device Dislodged or Dislocated 3 3
Loss of Osseointegration 3 3
Use of Device Problem 2 2
Failure to Align 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Detachment of Device or Device Component 2 2
Inaccurate Information 2 2
Overcorrection 1 1
Degraded 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 78 78
Failure of Implant 61 61
Pain 38 38
Implant Pain 20 20
Physical Asymmetry 17 17
Insufficient Information 15 15
Unspecified Infection 8 8
Discomfort 8 8
Therapeutic Response, Decreased 6 6
Post Operative Wound Infection 4 4
Bacterial Infection 4 4
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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