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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device passer, wire, orthopedic
Product CodeHXI
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
SAFEWIRE, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 2 2
2016 35 35
2017 7 7
2018 13 13
2019 1 1
2020 5 5
2021 2 2
2022 8 8
2023 12 12
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Break 28 28
Device Operates Differently Than Expected 22 22
Fracture 6 6
Appropriate Term/Code Not Available 6 6
Material Fragmentation 5 5
Detachment of Device or Device Component 5 5
Device Operational Issue 4 4
Device Slipped 4 4
Difficult to Insert 3 3
Use of Device Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Material Deformation 2 2
Mechanical Problem 2 2
Patient Device Interaction Problem 2 2
Difficult to Remove 1 1
Material Separation 1 1
Device Inoperable 1 1
Detachment Of Device Component 1 1
Degraded 1 1
Insufficient Information 1 1
Difficult to Advance 1 1
Metal Shedding Debris 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 17 17
No Information 17 17
No Consequences Or Impact To Patient 13 13
No Clinical Signs, Symptoms or Conditions 13 13
Foreign Body In Patient 9 9
Device Embedded In Tissue or Plaque 7 7
Insufficient Information 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
No Code Available 3 3
Blister 3 3
No Patient Involvement 3 3
Rash 3 3
Tissue Damage 1 1
Sedation 1 1
Ambulation Difficulties 1 1
Rheumatoid Arthritis 1 1
Cyst(s) 1 1
Bone Fracture(s) 1 1
Hypersensitivity/Allergic reaction 1 1
Inflammation 1 1
Necrosis 1 1
Pain 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Extremity Medical LLC II Mar-15-2013
2 Integra LifeSciences Corp. II Jun-28-2016
3 Interventional Spine Inc II Jul-01-2011
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