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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device reherniation reduction device
Definition The device is intended to reduce the incidence of reherniation, and reoperation following primary limited lumbar discectomy procedures (excision of herniated intervertebral disc).
Product CodeQES
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 0 3 3 0 0 1 2

MDR Year MDR Reports MDR Events
2020 19 19
2021 18 18
2022 22 22
2023 18 18
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 37 37
Device Dislodged or Dislocated 16 16
Fracture 10 10
Improper or Incorrect Procedure or Method 9 9
Migration 3 3
Failure to Seal 3 3
Malposition of Device 2 2
Insufficient Information 2 2
Unintended Movement 2 2
Device Difficult to Setup or Prepare 2 2
Off-Label Use 1 1
Difficult to Advance 1 1
Difficult to Insert 1 1
Material Twisted/Bent 1 1
Naturally Worn 1 1
Device Appears to Trigger Rejection 1 1
Deformation Due to Compressive Stress 1 1
Detachment of Device or Device Component 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hernia 30 30
Pain 15 15
Vertebral Fracture 10 10
No Clinical Signs, Symptoms or Conditions 6 6
Unspecified Infection 4 4
Hematoma 3 3
Nerve Damage 3 3
Numbness 3 3
Scar Tissue 3 3
Abscess 3 3
No Code Available 2 2
Post Operative Wound Infection 2 2
Prolapse 2 2
Joint Laxity 2 2
Bacterial Infection 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Emotional Changes 1 1
No Information 1 1
Implant Pain 1 1
Foreign Body Reaction 1 1
Seroma 1 1
Foreign Body In Patient 1 1
Osteolysis 1 1
Insufficient Information 1 1
Intervertebral Disc Compression or Protrusion 1 1
Spinal Cord Injury 1 1
Nervous System Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Intrinsic Therapeutics, Inc. II Aug-13-2020
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