inforMED
InjuryNBK

NUVASIVE POLYAXIAL SPINAL SCREWS

Received Jul 17, 2017 · Event occurred May 9, 2017

Report 2031966-2017-00091 · MDR key 6719905

Device

Generic name

Thoracolumbosacral Pedicle Screw System

Manufacturer

Nuvasive, Inc.

Model number

8806545006

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • No Information
  • No Information

Narrative

Additional Manufacturer Narrative

NO PRODUCT OR RADIOGRAPHS WERE PROVIDED FOR EVALUATION. ROD WAS REMOVED TO PERFORM DECOMPRESSION AND PLACED BACK. NO KNOWN MALFUNCTION NOR ALLEGATION OF PRODUCT PROBLEM REPORTED. REMAINS IN-SITU.

Description of Event or Problem

RECEIVED INFORMATION STATING, A PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2017. THE LEFT SIDE ROD WAS REMOVED TO PERFORM DECOMPRESSION AND THE ROD WAS PLACED BACK. NO ALLEGATION OF PRODUCT MALFUNCTION.