FDA Adverse Event Malfunction Summary report: N

SPHERICAL SCREW

MDR report key: 5213236 · Received November 10, 2015

Report

Report Number
5213236
Event Type
Malfunction
Date Received
November 10, 2015
Date of Event
August 21, 2015
Report Date
October 22, 2015
Manufacturer
NEXUS MEDICAL, LLC
Product Code
NKB
Adverse Event
Yes
Report Source
User Facility report
Reporter Location
FL, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

THE PATIENT HAD UNDERGONE A SPINAL ARTHRODESIS AND THEN WAS DOING VERY WELL WITH MINIMAL PAIN. THE PATIENT'S RADICULAR PAIN AND NEUROGENIC CLAUDICATION HAD RESOLVED AND THEY WERE VERY PLEASED. HOWEVER, THE POSTOPERATIVE X-RAYS SHOWED DISCONNECTION OF THE NEXUS INSTRUMENTATION. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM FOR REVISION OF INSTRUMENTATION. NOTES FROM THE OPERATIVE REPORT TWO MONTHS LATER: THE PREVIOUS INCISION WAS REOPENED DOWN THROUGH THE LUMBAR FASCIA AND THROUGH THE OLD SCAR TISSUE TO THE LEVEL OF THE SPINE. THIS WAS CAREFULLY DISSECTED OUT BILATERALLY. ON THE RIGHT SIDE, THE NEXUS INSTRUMENTATION WAS IDENTIFIED. THE ROD HAD COME OFF THE SCREW HEAD AT L5 AND WAS LOOSE AT S1 AS WELL. THIS WAS DISASSEMBLED AND THE ROD REMOVED. THE RIGHT S1 SCREW WAS REMOVED AND THE SCREW PATHWAY PROBED WITH THE BALL-ENDED PROBE. THIS APPEARED TO BE SOLID AND WITHOUT ANY TYPE OF FRACTURE OR CORTICAL BREACH. A NEW S1 PEDICLE SCREW WAS PLACED USING LATERAL FLUOROSCOPIC GUIDANCE. THE NEW SCREW SYSTEM USED WAS MEDTRONIC SOFAMOR DANEK SOLERA. THE PREVIOUS SCREWS WERE IN FACT 7.5 MM DIAMETER AND WE WERE ABLE TO USE 7.5 MM DIAMETER SCREWS AGAIN SINCE THE SCREW THREAD PITCH WAS QUITE DIFFERENT. THE SCREW WAS EXTREMELY SOLID GOING IN. IT WAS ADVANCED JUST A BIT FURTHER THAN THE PREVIOUS ONE WHICH ALLOWED AN EVEN STRONGER HOLD. AFTER THE RIGHT S1 SCREW WAS REPLACED. THE RIGHT L5 SCREW WAS REMOVED AND REPLACED IN THE EXACT SAME MANNER. ATTENTION WAS SHIFTED TO THE LEFT SIDE. THIS WAS ALL INTACT. HOWEVER, I FELT IT WAS IMPORTANT TO REMOVE AND REPLACE TO THE NEW SYSTEM TO MAKE IT SYMMETRICAL AND ALSO TO PLACE A CROSS CONNECTOR." .....THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO APPARENT COMPLICATIONS. RISK MGMT NOTE: 2 SCREWS AND 1 ROD WERE RETURNED TO THE FIELD REP. IT WAS NOT CLEAR WHICH ROD (20MM OR 22MM) WAS RETURNED, SO AM PROVIDING INFORMATION ON BOTH IN THIS REPORT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
746228 SPHERICAL SCREW ORTHOSIS, SPINAL PEDICLE FIXATION NKB NEXUS MEDICAL, LLC 7.5 X 55 999-15623

Patients

Seq Age Sex Outcome Treatment
1 68 YR