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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 2
CAMBER SPINE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
COORSTEK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 2
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
FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES
  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
HUVEXEL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ILION MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
L & K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
LESSPINE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC SOFAMOR DANEK
  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 21
SI-TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 2
SICAGE LLC
  SUBSTANTIALLY EQUIVALENT 1
SIJ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SIMPLICITY LLC
  SUBSTANTIALLY EQUIVALENT 2
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINUS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 4
TENON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
VGI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZYGA TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2014 146 146
2015 119 119
2016 122 122
2017 157 157
2018 137 137
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 612 612
Adverse Event Without Identified Device or Use Problem 301 301
Loss of Osseointegration 99 99
Inadequacy of Device Shape and/or Size 66 66
Insufficient Information 56 56
Failure to Osseointegrate 25 25
Positioning Problem 21 21
Appropriate Term/Code Not Available 17 17
Device Operates Differently Than Expected 15 15
Difficult to Remove 14 14
Break 12 12
Improper or Incorrect Procedure or Method 10 10
Migration or Expulsion of Device 8 8
Device Handling Problem 7 7
Device Dislodged or Dislocated 6 6
Device Slipped 5 5
Loose or Intermittent Connection 5 5
Patient-Device Incompatibility 5 5
Entrapment of Device 4 4
Fracture 4 4
Device Damaged by Another Device 4 4
Use of Device Problem 4 4
Migration 3 3
Material Fragmentation 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Patient Device Interaction Problem 2 2
Contamination 2 2
Detachment of Device or Device Component 2 2
Difficult to Advance 2 2
Fitting Problem 2 2
Difficult to Insert 1 1
Failure To Adhere Or Bond 1 1
Component Missing 1 1
Structural Problem 1 1
Bent 1 1
Solder Joint Fracture 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Contamination of Device Ingredient or Reagent 1 1
Material Protrusion/Extrusion 1 1
No Apparent Adverse Event 1 1
Material Integrity Problem 1 1
Unintended Movement 1 1
Device Markings/Labelling Problem 1 1
Failure to Advance 1 1
Protective Measures Problem 1 1
Incomplete or Inadequate Connection 1 1
Unexpected Therapeutic Results 1 1
Human-Device Interface Problem 1 1
Cut In Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Arthralgia 437 437
Undesired Nerve Stimulation 417 417
Pain 319 319
Joint Disorder 82 82
Nerve Proximity Nos (Not Otherwise Specified) 72 72
No Code Available 27 27
Bone Fracture(s) 26 26
Hematoma 18 18
Hemorrhage/Bleeding 15 15
Physical Entrapment 15 15
No Known Impact Or Consequence To Patient 15 15
Fall 13 13
Bacterial Infection 11 11
Unspecified Infection 10 10
Inadequate Pain Relief 9 9
Numbness 9 9
No Information 8 8
Cellulitis 8 8
Patient Problem/Medical Problem 6 6
Hypersensitivity/Allergic reaction 6 6
Failure of Implant 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Device Embedded In Tissue or Plaque 4 4
Pulmonary Embolism 4 4
Pseudoaneurysm 4 4
Insufficient Information 4 4
Osteopenia/ Osteoporosis 3 3
Cardiac Arrest 3 3
Ambulation Difficulties 3 3
Irritation 3 3
Burning Sensation 3 3
Tingling 3 3
Foreign Body In Patient 3 3
Disc Impingement 3 3
Therapeutic Response, Decreased 3 3
Implant Pain 3 3
Dyspnea 3 3
Perforation of Vessels 3 3
Blood Loss 2 2
Post Operative Wound Infection 2 2
Death 2 2
No Consequences Or Impact To Patient 2 2
Complaint, Ill-Defined 2 2
Chest Pain 2 2
Thrombosis 2 2
Discomfort 2 2
Respiratory Distress 2 2
Joint Laxity 2 2
Test Result 2 2
Impaired Healing 1 1

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