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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
BIOFUSION MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
COORSTEK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUTTING EDGE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HUVEXEL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ILION MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 5
ORTHOFUNDAMENTALS, LLC
  SUBSTANTIALLY EQUIVALENT 1
OSSEUS FUSION SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SI-BONE, INC
  SUBSTANTIALLY EQUIVALENT 1
SI-BONE, INC.
  SUBSTANTIALLY EQUIVALENT 6
SICAGE LLC
  SUBSTANTIALLY EQUIVALENT 1
SIJ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
SPINUS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TENON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 122 122
2017 157 157
2018 137 137
2019 175 175
2020 148 148
2021 154 154
2022 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 516 516
Adverse Event Without Identified Device or Use Problem 255 255
Loss of Osseointegration 99 99
Inadequacy of Device Shape and/or Size 53 53
Failure to Osseointegrate 19 19
Insufficient Information 12 12
Appropriate Term/Code Not Available 6 6
Break 6 6
Migration or Expulsion of Device 6 6
Use of Device Problem 4 4
Patient-Device Incompatibility 3 3
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Migration 3 3
Difficult to Advance 2 2
Patient Device Interaction Problem 2 2
Device Operates Differently Than Expected 2 2
Improper or Incorrect Procedure or Method 2 2
Fitting Problem 2 2
Fracture 2 2
Device Slipped 1 1
Unstable 1 1
Difficult to Remove 1 1
Entrapment of Device 1 1
Solder Joint Fracture 1 1
Contamination of Device Ingredient or Reagent 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Device Damaged by Another Device 1 1
Structural Problem 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Handling Problem 1 1
Incomplete or Inadequate Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Arthralgia 415 415
Undesired Nerve Stimulation 392 392
Pain 116 116
Joint Disorder 66 66
Nerve Proximity Nos (Not Otherwise Specified) 51 51
Bone Fracture(s) 21 21
Bacterial Infection 11 11
Hematoma 10 10
No Known Impact Or Consequence To Patient 10 10
Hemorrhage/Bleeding 9 9
No Code Available 8 8
Cellulitis 7 7
Fall 6 6
Patient Problem/Medical Problem 6 6
No Information 6 6
Hypersensitivity/Allergic reaction 5 5
Failure of Implant 4 4
Unspecified Infection 3 3
Cardiac Arrest 3 3
Numbness 3 3
Ambulation Difficulties 3 3
Implant Pain 3 3
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Osteopenia/ Osteoporosis 2 2
Blood Loss 2 2
Pseudoaneurysm 2 2
Inadequate Pain Relief 2 2
No Consequences Or Impact To Patient 2 2
Discomfort 1 1
Injury 1 1
Disability 1 1
Chest Pain 1 1
Death 1 1
Reaction 1 1
Osteolysis 1 1
Inflammation 1 1
Irritation 1 1
Nerve Damage 1 1
Rash 1 1
Respiratory Distress 1 1
Septic Shock 1 1
Thrombosis 1 1
Perforation of Vessels 1 1
Weakness 1 1
Burning Sensation 1 1
Tingling 1 1
Foreign Body In Patient 1 1
Missing Value Reason 1 1
Malunion of Bone 1 1
Vascular Dissection 1 1

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