inforMED
InjuryOSH

RESPONSE 5.5 SPINE SYSTEM

Received Jan 6, 2017 · Event occurred Dec 7, 2016

Report 3006460162-2016-04355 · MDR key 6229482

Device

Generic name

Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis

Catalog number

00-1003-4355

Product problems

  • Fracture
  • Fracture

Patient

Not reported

  • Congenital Defect/Deformity
  • Congenital Defect/Deformity

Narrative

Additional Manufacturer Narrative

INITIAL REPORT FILED PRIOR TO SCHEDULED REVISION SURGERY. RETURN OF FRACTURED SCREWS FOR EVALUATION HAS BEEN REQUESTED. IF DEVICES ARE RETURNED, THEY WILL BE EVALUATED AND A FOLLOW UP REPORT SUBMITTED.

Description of Event or Problem

THE PROXIMAL PORTION OF BOTH PEDICLE SCREWS BROKE OFF. THE SCREWS WERE LOCATED AT THE BOTTOM OF THE CONSTRUCT AT L3 AS PART OF A T5-L3 FUSION. ORIGINAL DATE OF SURGERY WAS (B)(6) 2014.