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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pusher, socket
Product CodeHXO
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 3 3
2016 4 4
2017 5 5
2018 1 1
2021 2 2
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 8 8
Fracture 5 5
Device Operates Differently Than Expected 2 2
Bent 2 2
Device Dislodged or Dislocated 1 1
Positioning Problem 1 1
Detachment Of Device Component 1 1
Positioning Failure 1 1
Device Issue 1 1
Device Or Device Fragments Location Unknown 1 1
Component or Accessory Incompatibility 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Device Embedded In Tissue or Plaque 3 3
No Information 3 3
No Code Available 2 2
No Known Impact Or Consequence To Patient 2 2
Unspecified Infection 1 1
Foreign Body In Patient 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Oct-14-2010
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