NUVASIVE RELINE SYSTEM
Received Jul 11, 2017 · Event occurred Sep 8, 2016
Report 2031966-2017-00080 · MDR key 6704687
Device
Product problems
- Fracture
- Fracture
Patient
60 YR
- Failure of Implant
- Failure of Implant
Narrative
Additional Manufacturer Narrative
NO PRODUCT WAS RETURNED FOR INVESTIGATION NOR WERE RADIOGRAPHS PROVIDED TO CONFIRM THE EVENT. INFORMATION RECEIVED FROM THE PHYSICIAN INDICATES PATIENT WAS DIAGNOSED WITH PSEUDOARTHROSIS 15 MONTHS POST INITIAL SURGERY. LABELING REVIEW: "...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: BENDING, FRACTURE OR LOOSENING OF IMPLANT COMPONENT(S)..."
Description of Event or Problem
ON (B)(6) 2016, PATIENT HEARD A "POP" AND WAS EXPERIENCING BACK PAIN. PATIENT WAS DIAGNOSED WITH "A BROKEN ROD". IT WAS REPORTED A CT SCAN OF THE SPINE INDICATED A FRACTURE OF THE CONNECTOR RODS. ON (B)(6) 2016, PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE FRACTURED ROD AND REVISE THE INSTRUMENTATION.