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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

Device Problems
Break 12
Device remains implanted 3
Fracture 3
No Known Device Problem 3
Not Applicable 2
Malposition of device 2
Implant breakage or physical damage 2
Implant, removal of 2
Implant, repositioning of 1
Malfunction 1
Device or device fragments location unknown 1
Device operates differently than expected 1
Loose 1
Mechanical issue 1
Misplacement 1
Device, or device fragments remain in patient 1
Failure to osseointegrate 1
Material discolored 1
Total Device Problems 39

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