InjuryNBK
NUVASIVE POLYAXIAL SPINAL SCREWS
Received Jul 17, 2017
Report 2031966-2017-00084 · MDR key 6718061
Device
Generic name
Thoracolumbosacral Pedicle Screw System
Manufacturer
Nuvasive, Inc.Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Information
- No Known Impact Or Consequence To Patient
- No Information
Narrative
Additional Manufacturer Narrative
NO PRODUCT HAS BEEN RETURNED FOR INVESTIGATION. NO RADIOGRAPHS OR FURTHER INFORMATION IS AVAILABLE TO BE ABLE TO DETERMINE ROOT CAUSE.
Description of Event or Problem
RECEIVED INFORMATION STATING PATIENT UNDERWENT A REVISION SURGERY FROM L3-S1 LEVELS WHERE THE PRECEPT PRODUCT WAS REMOVED. NO ALLEGATION OF PRODUCT MALFUNCTION.