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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intervertebral body graft containment device
Definition An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.
Product CodeOQB
Regulation Number 888.3085
Device Class 2


Premarket Reviews
ManufacturerDecision
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEOLOGY, INC.
  GRANTED 1

MDR Year MDR Reports MDR Events
2021 1 1
2022 2 2
2023 7 7
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 5 5
Expulsion 4 4
Insufficient Information 2 2
Improper or Incorrect Procedure or Method 2 2
Malposition of Device 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pain 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Failure of Implant 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body In Patient 1 1
Insufficient Information 1 1
Perforation of Vessels 1 1
Unspecified Vascular Problem 1 1

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