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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sacroiliac joint fixation
Definition sacroiliac joint fusion
Product CodeOUR
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED RESEARCH MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
AEGIS SPINE
  SUBSTANTIALLY EQUIVALENT 1
AEGIS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALEVIO, LLC
  SUBSTANTIALLY EQUIVALENT 2
ANJALI INVESTMENTS L.L.C
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AURORA SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOFUSION MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUTTING EDGE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
DELTACOR GMBH
  SUBSTANTIALLY EQUIVALENT 1
DIO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
FOUNDATION FUSION SOLUTIONS, LLC (DBA CORNERLOC)
  SUBSTANTIALLY EQUIVALENT 2
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HT MEDICAL D.B.A. XENIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HT MEDICAL LLC DBA XENIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ILION MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
L & K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LESSPINE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 5
ORTHOFUNDAMENTALS, LLC
  SUBSTANTIALLY EQUIVALENT 1
OSSEUS FUSION SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
SAIL FUSION, LLC
  SUBSTANTIALLY EQUIVALENT 1
SI-BONE INC.
  SUBSTANTIALLY EQUIVALENT 2
SI-BONE, INC
  SUBSTANTIALLY EQUIVALENT 1
SI-BONE, INC.
  SUBSTANTIALLY EQUIVALENT 8
SI-TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SIMPLICITY LLC
  SUBSTANTIALLY EQUIVALENT 2
SPINUS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 4
TENON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VGI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 175 175
2020 148 148
2021 154 154
2022 23 23
2023 7 7
2024 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 317 317
Adverse Event Without Identified Device or Use Problem 106 106
Loss of Osseointegration 83 83
Inadequacy of Device Shape and/or Size 45 45
Insufficient Information 6 6
Appropriate Term/Code Not Available 5 5
Material Fragmentation 3 3
Break 3 3
Migration 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 2 2
Migration or Expulsion of Device 2 2
Patient Device Interaction Problem 2 2
Device Markings/Labelling Problem 1 1
Solder Joint Fracture 1 1
Component Missing 1 1
Failure to Osseointegrate 1 1
Structural Problem 1 1
Incomplete or Inadequate Connection 1 1
Packaging Problem 1 1
Difficult to Remove 1 1
Therapeutic or Diagnostic Output Failure 1 1
Fitting Problem 1 1
No Apparent Adverse Event 1 1
Patient-Device Incompatibility 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Undesired Nerve Stimulation 230 230
Arthralgia 215 215
Bone Fracture(s) 21 21
Pain 14 14
Hemorrhage/Bleeding 9 9
Bacterial Infection 8 8
No Known Impact Or Consequence To Patient 6 6
Hematoma 6 6
Cellulitis 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Hypersensitivity/Allergic reaction 4 4
Insufficient Information 4 4
Implant Pain 3 3
Failure of Implant 3 3
Fall 3 3
Blood Loss 2 2
Patient Problem/Medical Problem 2 2
Post Operative Wound Infection 2 2
Inadequate Pain Relief 2 2
Pseudoaneurysm 2 2
Joint Laxity 2 2
Ambulation Difficulties 1 1
Thrombosis 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Vascular Dissection 1 1
Low Blood Pressure/ Hypotension 1 1
Unspecified Infection 1 1
Malunion of Bone 1 1
Post Traumatic Wound Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Discomfort 1 1
Missing Value Reason 1 1
Ossification 1 1
Thrombosis/Thrombus 1 1
Swelling/ Edema 1 1
No Code Available 1 1
Death 1 1
Foreign Body In Patient 1 1
Non-union Bone Fracture 1 1

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