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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device implant, fixation device, spinal
Regulation Description Spinal intervertebral body fixation orthosis.
Product CodeJDN
Regulation Number 888.3060
Device Class 2


Premarket Reviews
ManufacturerDecision
DEPUY INTL., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Implant breakage or physical damage 10
Break 9
Internal fixation, revision of 6
Implant, removal of 4
Implant, repositioning of 3
Locking mechanism failure 2
Dissection 2
Mechanical issue 2
Device remains implanted 2
Patient-device incompatibility 2
Detachment of device or device component 1
Device operates differently than expected 1
Dislodged or dislocated 1
Incompatibility problem 1
Material integrity issue 1
No Known Device Problem 1
No Information 1
No code available 1
Tip breakage 1
Other (for use when an appropriate device code cannot be identified) 1
Migration of device or device component 1
Explanted 1
Fracture 1
Malposition of device 1
Total Device Problems 56

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