inforMED
MalfunctionOSH

MEDTRONIC SCREW EXTENDER

Received Jan 3, 2020 · Event occurred Dec 27, 2019

Report MW5092025 · MDR key 9552546

Device

Generic name

Pedicle Screw Spinal System Adolescent Idiopathic Scoliosis

Manufacturer

Medtronic, Inc.

Model number

7578302

Product problems

  • Break
  • Detachment of Device or Device Component

Patient

Not reported

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

PT WENT POSTERIOR THORACIC DECOMPRESSION, T 8-10 INSTRUMENTATION, FUSION, DURING THE SURGERY WHILE USING THE MEDTRONIC SCREW EXTENDER, 2 PIECES BROKE OFF THE MAIN BODY AND WERE IMMEDIATELY RECOVERED. FDA SAFETY REPORT ID# (B)(4).