inforMED
InjuryEZX

SPINEOLOGY ACCESS PORTAL

Received Feb 6, 2008 · Event occurred Feb 5, 2008

Report 992400 · MDR key 992400

Device

Generic name

Cannula

Manufacturer

Spineology

Model number

311-089

Lot number

UM05002

Product problems

  • Break
  • Device, or device fragments remain in patient
  • Difficult to Remove

Patient

49 YR

  • Nonresorbable materials, unretrieved in body

Narrative

Description of Event or Problem

MALE PT UNDERGOING VERTEBRAL INTERBODY FUSION. ATTEMPTED SPINEOLOGY BONE BAG SYSTEM. INSTRUMENTATION BROKE, UNABLE TO RETRIEVE STEEL SHARDS FROM FRACTURED ACCESS PORTAL. INSTRUMENTATION FAILURE LEADING TO RETAINED STEEL SHARDS/PIECES IN SPINE. (WITH IN L5-S1 DISK SPACE).