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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 1

MDR Year MDR Reports MDR Events
2020 19 19
2021 18 18
2022 22 22
2023 18 18
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 34 34
Device Dislodged or Dislocated 15 15
Fracture 10 10
Improper or Incorrect Procedure or Method 9 9
Device Difficult to Setup or Prepare 2 2
Unintended Movement 2 2
Migration 2 2
Failure to Seal 2 2
Material Twisted/Bent 1 1
Naturally Worn 1 1
Off-Label Use 1 1
Material Separation 1 1
Difficult to Insert 1 1
Malposition of Device 1 1
Deformation Due to Compressive Stress 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hernia 29 29
Pain 14 14
Vertebral Fracture 10 10
No Clinical Signs, Symptoms or Conditions 6 6
Scar Tissue 3 3
Hematoma 3 3
Unspecified Infection 3 3
Nerve Damage 3 3
Abscess 3 3
Bacterial Infection 2 2
Numbness 2 2
Post Operative Wound Infection 2 2
Prolapse 2 2
No Code Available 2 2
Joint Laxity 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body In Patient 1 1
Nervous System Injury 1 1
No Information 1 1
Spinal Cord Injury 1 1
Intervertebral Disc Compression or Protrusion 1 1
Emotional Changes 1 1
Foreign Body Reaction 1 1

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