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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device growing rod system
Definition Stabilization or correction of spinal deformities without the use of fusion.
Product CodePGM
Regulation Number 888.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1 1
2022 5 5
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Adverse Event Without Identified Device or Use Problem 3 3
Material Twisted/Bent 2 2
Migration 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Bacterial Infection 1 1
Death 1 1
High Blood Pressure/ Hypertension 1 1
Inflammation 1 1
Laceration(s) 1 1
Necrosis 1 1
Nerve Damage 1 1
Pain 1 1
Paralysis 1 1
Skin Discoloration 1 1
Blood Loss 1 1
Unspecified Nervous System Problem 1 1
Unspecified Mental, Emotional or Behavioural Problem 1 1
Skin Burning Sensation 1 1

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