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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 14 14

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
Appropriate Term/Code Not Available 7 7
Insufficient Information 6 6
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Migration 3 3
Break 3 3
Material Fragmentation 3 3
Migration or Expulsion of Device 2 2
Improper or Incorrect Procedure or Method 2 2
Use of Device Problem 2 2
Patient Device Interaction Problem 2 2
Patient-Device Incompatibility 1 1
Device Markings/Labelling Problem 1 1
Incomplete or Inadequate Connection 1 1
Failure to Osseointegrate 1 1
Structural Problem 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Fitting Problem 1 1
Component Missing 1 1
Solder Joint Fracture 1 1
Difficult to Remove 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 Clinical Signs, Symptoms or Conditions 6 6
Hematoma 6 6
Cellulitis 6 6
No Known Impact Or Consequence To Patient 6 6
Hypersensitivity/Allergic reaction 4 4
Insufficient Information 4 4
Failure of Implant 3 3
Implant Pain 3 3
Fall 3 3
Patient Problem/Medical Problem 2 2
Blood Loss 2 2
Post Operative Wound Infection 2 2
Post Traumatic Wound Infection 2 2
Joint Laxity 2 2
Pseudoaneurysm 2 2
Inadequate Pain Relief 2 2
Unspecified Infection 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Death 1 1
No Code Available 1 1
Vascular Dissection 1 1
No Information 1 1
Ossification 1 1
Foreign Body In Patient 1 1
Thrombosis/Thrombus 1 1
Thrombosis 1 1
Discomfort 1 1
Missing Value Reason 1 1
Malunion of Bone 1 1
Non-union Bone Fracture 1 1
Swelling/ Edema 1 1
Low Blood Pressure/ Hypotension 1 1
Ambulation Difficulties 1 1
Device Embedded In Tissue or Plaque 1 1

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