InjuryMNI
INERTIA PEDICLE SCREW SYSTEM
Received Oct 24, 2018 · Event occurred Sep 19, 2017
Report 3007922509-2018-00004 · MDR key 8002061
Device
Generic name
Inertia Pedicle Screw System
Manufacturer
Nexxt Spine LlcModel number
10-60-4530Catalog number
10-60-4530
Lot number
NS5996A
Product problems
- Use of Device Problem
- Improper or Incorrect Procedure or Method
- Use of Device Problem
- Improper or Incorrect Procedure or Method
Patient
62 YR
- Patient Problem/Medical Problem
- Patient Problem/Medical Problem
Narrative
Additional Manufacturer Narrative
ADVISED SURGEON NOT TO USE FUSION BASED HARDWARE WITH NON-FUSION BASED HARDWARE.
Description of Event or Problem
FUSION DID NOT OCCUR AS INTENDED, RESULTING IN CONSTRUCT FAILURE AND ULTIMATELY SCREW FRACTURE. CONSTRUCT WAS IMPLANTED OFF-LABEL IN THAT THE PEDICLE SCREW FUSION HARDWARE WAS PAIRED WITH A NON-FUSION COFLEX IMPLANT OF ANOTHER MANUFACTURER.
Remedial action
- Other