MalfunctionOSH

CREO

Received Sep 16, 2019 · Event occurred Aug 16, 2019

Report 9069584 · MDR key 9069584

Device

Generic name

Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Manufacturer

Globus Medical, Inc.

Model number

1134.0100

Catalog number

1134.0100

Product problems

Break

Patient

25185 DA

Failure of Implant
Device Embedded In Tissue or Plaque
Failure of Implant
Device Embedded In Tissue or Plaque

Narrative

Description of Event or Problem

PATIENT RETURNED TO THE OPERATING ROOM 72 HOURS STATUS POST L4-L5, L5-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION. IMAGING INDICATED THAT THE LEFT S1 SCREW TULIP HAD BROKEN OFF. LUMBAR SPINE HARDWARE REVISION WITH REMOVAL AND REPLACEMENT OF LEFT S1 PEDICLE SCREW.