NUVASIVE POLYAXIAL SPINAL SCREWS
Received Sep 26, 2017 · Event occurred Aug 31, 2017
Report 2031966-2017-00127 · MDR key 6893449
Device
Generic name
Thoracolumbosacral Pedicle Screw System
Manufacturer
Nuvasive, Inc.Product problems
- Unintended Movement
- Unintended Movement
Patient
Not reported
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
NO PRODUCT HAS BEEN RETURNED FOR EVALUATION NOR WERE X-RAYS PROVIDED TO CONFIRM THE EVENT. POTENTIAL ADVERSE EVENTS AND COMPLICATIONS "AS WITH ANY MAJOR SURGICAL PROCEDURES, THERE ARE RISKS INVOLVED IN ORTHOPEDIC SURGERY. INFREQUENT OPERATIVE AND POSTOPERATIVE COMPLICATIONS THAT MAY RESULT IN THE NEED FOR ADDITIONAL SURGERIES INCLUDE; LOSS OF SENSORY AND/OR MOTOR FUNCTION..." "POTENTIAL RISKS IDENTIFIED WITH THE USE OF THIS SYSTEM, WHICH MAY REQUIRE ADDITIONAL SURGERY, INCLUDE: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S) PAIN, DISCOMFORT OR ABNORMAL SENSATIONS DUE TO THE PRESENCE OF THE DEVICE..." NO PRODUCT RETURNED FOR EVALUATION.
Description of Event or Problem
IN (B)(6) 2016, A PATIENT UNDERWENT POSTERIOR SPINAL FUSION AT THE T9-L3 LEVELS. REPORTEDLY, THE PATIENT DEVELOPED POST-OPERATIVE RADICULOPATHY DUE TO SCREW LOOSENING AT RIGHT SIDE OF THE L3 LEVEL. ON (B)(6) 2017, A REVISION PROCEDURE WAS PERFORMED TO REPLACE THE LOOSENED SCREW AND EXTEND THE CONSTRUCT TO THE L5 LEVEL. NO PATIENT INJURY WAS REPORTED.