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TPLC
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show TPLC since
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2024
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Device
passer, wire, orthopedic
Product Code
HXI
Regulation Number
888.4540
Device Class
1
Premarket Reviews
Manufacturer
Decision
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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