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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
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXI
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2015 2 2
2016 35 35
2017 7 7
2018 13 13
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Device Operates Differently Than Expected 22 22
Break 9 9
Appropriate Term/Code Not Available 5 5
Device Operational Issue 4 4
Device Slipped 4 4
Material Fragmentation 3 3
Difficult to Insert 3 3
Mechanical Problem 2 2
Use of Device Problem 2 2
Fracture 2 2
Material Deformation 2 2
Tip 2 2
Insufficient Information 1 1
Metal Shedding Debris 1 1
Improper or Incorrect Procedure or Method 1 1
Difficult to Advance 1 1
Device Inoperable 1 1
Detachment Of Device Component 1 1
Degraded 1 1
Wire 1 1
Guidewire 1 1
Screw 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 17 17
No Information 16 16
No Consequences Or Impact To Patient 13 13
Device Embedded In Tissue or Plaque 5 5
No Patient Involvement 3 3
No Code Available 3 3
Tissue Damage 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Integra LifeSciences Corp. II Jun-28-2016
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