CD HORIZON® FENESTRATED SCREW SET

Additional Manufacturer Narrative

RADIOGRAPHIC IMAGE REVIEW STATES, LATERAL XRAY L4-5 INTERBODY FUSION L2-3, 4 SAME PRESENT CEMENT AUGMENTATION AT L1, L2-4. AP XRAY OF 1, STAPLES PRESENT. AP XRAY, ROD APPEARS DISPLACED FOR SCREW TULIP AT TOP LEVEL ON ONE SIDE CAPTURED TO 2. LATERAL XRAY, SCREW TULIP ANGLED SUPERIORLY ON ONE SIDE AT TOP LEVEL, ROD OUT OF TULIP. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT HAVING SPINAL THERAPY. PREOPERATIVE DIAGNOSIS OF THIS SURGERY WAS SPINAL CANAL STENOSIS. IT WAS REPORTED THAT THE PATIENT WITH OSTEOPOROSIS, FENESTRATED SET SCREW (FNS) WAS SELECTED AND THE ROD WAS REMOVED FROM THE HEAD 2 WEEKS AFTER THE SURGERY, AND THE SET SCREW REMAINED IN THE SCREW HEAD. ACCORDING TO THE PHYSICIAN, CROSS-THREADING WAS NOT PERFORMED. THE SCREW WAS NOT SLACKENED, SO THE CY INSERTED IN L2/3 WAS KINKING, SO THERE WAS AN INQUIRY WHETHER IT IS POSSIBLE FOR ONLY THE ROD TO COME OFF WITHOUT THE SET SCREW COMING OFF. IT IS POSSIBLE THAT THE SET SCREW WAS NOT CRIMPED DUE TO THE MOST CRANIAL SIDE SCREW. THE ROD MIGHT NOT BE DIRECTLY RELATED, AND NO FRACTURE OF THE ROD WAS OBSERVED. AND IT DID NOT FEEL THAT THE SCREW HEAD HAD BEEN REMOVED. BUT THERE IS NO LOOSENING OF SCREW HAPPENED. ALTHOUGH THERE WAS NO PROCEDURAL DELAY, THE PATIENT REQUIRED EXTENDED HOSPITALIZATION AND A RE-OPERATION IS SCHEDULED ON (B)(6) 2025, DESPITE NO SYMPTOMS DEVELOPING FROM THE EVENT. BONE FUSION IS INCOMPLETE, BUT RECOVERY IS ONGOING. ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE THAT THE REOPERATION WHICH PLANNED ON (B)(6) 2025 WAS SUCCESSFULLY COMPLETED. THE LEFT SIDE OF THE SET SCREW WAS COMPLETELY DISCONNECTED. AS FOR THE RIGHT SIDE, IT SEEMS THAT THERE IS NO LOOSENESS IN THE STATE THAT REMAINS ON THE HEAD. 55750026545, 1555106060, AND 6541104 HAVE BEEN REMOVED AND SENT TO JAPAN QA. NO DAMAGE OBSERVED IN PLI# 30. PLI# 40 AND PLI# 50 DON'T KNOW WHICH SET SCREW IT IS, BUT WHEN REP CHECKED THE NIPPLE, IT SEEMED THAT ONLY HALF OF IT WAS CRUSHED. BOTH PLI# 60 AND PLI# 70 WAS JUDGED THAT THERE IS NO PARTICULAR PROBLEM, AND IT IS PLACED IN THE BODY AS IT IS. THE CY REFERS TO CATALYFT PL. THE TERM SINKING REFERS TO IT IS DEPRESSED DOWNWARD AND HAS ENTERED THE VERTEBRAL BODY. THE ALLEGATION ON PLI# 20 WAS THE SET SCREW WAS NOT CRIMPED. IT HAS BEEN SAID THAT THE LOAD WAS ON THE HEAD AND THAT THE HEAD MAY NOT HAVE BEEN CONSTRUCTED AT 90° WITH THE ROD BECAUSE OF THE COMPRESSION. THE TYPE OF PROCEDURE INVOLVED DURING THE EVENT WAS POSTERIOR LUMBAR FIXATION PPS, TLIF AT L2-4 LEVELS. THERE WAS NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT INITIALLY AND AFTER REOPERATION.

Additional Manufacturer Narrative

E1: FIRST NAME AND LAST NAME OF INITIAL REPORTER IS UNKNOWN. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Additional Manufacturer Narrative

H3: PRODUCT ANALYSIS OF PRODUCT:55750026545, LOT:H5749806 AFTER VISUAL AND OPTICAL EXAMINATION AND FUNCTIONAL TESTING, IT DOES NOT APPEAR TO BE ANY DAMAGE, NOR DOES IT INDICATE ANY FUNCTIONAL ISSUES WITH THE SCREW. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.