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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spinous process plate
Regulation Description Spinal interlaminal fixation orthosis.
Definition A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor. It is not intended for stand-alone use.
Product CodePEK
Regulation Number 888.3050
Device Class 2


Premarket Reviews
ManufacturerDecision
AURORA SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIO MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
FLOSPINE
  SUBSTANTIALLY EQUIVALENT 1
LESPINE INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SIMPLICITY, LLC
  SUBSTANTIALLY EQUIVALENT 6
WENZEL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 17 17
2022 11 11
2023 8 8
2024 5 5
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Material Fragmentation 23 23
Break 5 5
Premature Separation 5 5
Patient-Device Incompatibility 3 3
Detachment of Device or Device Component 3 3
Mechanical Problem 1 1
Unintended Movement 1 1
Defective Device 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Difficult or Delayed Separation 1 1
Material Separation 1 1
Fracture 1 1
Device Dislodged or Dislocated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35 35
Insufficient Information 6 6
Unspecified Musculoskeletal problem 2 2
Failure of Implant 2 2
Pain 1 1
Spinal Column Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 XTANT Medical II Jan-28-2022
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