inforMED

SPINEOLOGY

Received Jul 21, 2006 · Event occurred Jul 13, 2006

Report MW1039820 · MDR key 748998

Device

Generic name

Optimesh 1500e

Manufacturer

Spineology

Model number

3302505

Catalog number

*

Lot number

505012

Product problems

  • Difficult to Insert
  • Device, or device fragments remain in patient
  • Sticking
  • Tip breakage

Patient

46 YR

  • Nonresorbable materials, unretrieved in body

Narrative

Description of Event or Problem

MESH INSERTION DID NOT RELEASE. SURGEON LEFT DISC METAL TIP IN SPACE DURING SURGERY.