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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 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Expulsion 4 4
Device Dislodged or Dislocated 3 3
Insufficient Information 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Malposition of Device 1 1
Detachment of Device or Device Component 1 1

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

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