CD HORIZON® FENESTRATED SCREW SET

Additional Manufacturer Narrative

D3: MFG DETAILS CORRECTED. H6: DEVICE CODES (FDD/ANNEX A) CORRECTED. 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 IMPLANTED WITH SCREW H AVING T11 - L3 REPAIR OF BURST FRACTURE THERAPY. IT WAS REPORTED THAT PATIENT HAD PRESENTED IN CLINIC WITH BACK PAIN AND A LUMP ABOVE THE STAB INCISION. FOLLOWING ANTIBIOTICS, PAIN AND LUMP WAS STILL VISIBLE AND X-RAY CONFIRMED THAT TAB WAS STILL ATTACHED TO THE SCREW HEAD. AS PER SURGEON, WHEN DR BROKE THE TOWERS IT SNAPPED OFF HALF OF THE TAB HEAD. VOYAGER SCREW TAB WAS LEFT IN PATIENT. TWO FULL EXTENDER TABS (NOT SCREW TAB) WERE LEFT INSIDE THE PATIENT AND WAS NOT BROKEN OFF FROM THE VOYAGER SCREW HEAD. SURGEON REOPERATED ON THE PATIENT ON (B)(6) 2024. PATIENT HAD SUCCESSFUL REMOVAL OF 2 TABS ON T11. PRODUCT WAS NOT USED CORRECTLY ACCORDING TO THE IFU/LABELING. PATIENT HAD REPORTED INFECTION AND PAIN AS A RESULT OF THE EVENT. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.

Additional Manufacturer Narrative

H6 - NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. 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.