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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device spinal pedicle screw, fixation, appliance system
Product CodeMCV
Device Class 3

MDR Year MDR Reports MDR Events
2014 30 30
2015 2 2
2016 1 1
2019 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 13
Break 8 8
Positioning Problem 7 7
Fracture 2 2
Mechanical Problem 1 1
Device Slipped 1 1
Failure to Osseointegrate 1 1
Crack 1 1
Degraded 1 1
Unintended Ejection 1 1
Noise, Audible 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 9 9
No Consequences Or Impact To Patient 6 6
Unspecified Infection 5 5
Cerebrospinal Fluid Leakage 4 4
Bone Fracture(s) 4 4
Failure of Implant 3 3
Pain 1 1
Injury 1 1
Foreign Body In Patient 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1

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