CAPSTONE PEEK

Description of Event or Problem

LITERATURE WAS REVIEWED REGARDING LATERAL LUMBAR INTERBODY FUSION WITH LATERAL PLATING: TECHNIQUES, FEASIBILITY AND EFFICACY. THE FOLLOWING MEDTRONIC DEVICES WERE USED: MEDTRONIC INFUSE AND PEEK CAGE AMONG PATIENTS' ADVERSE EVENTS/DEVICE PERFORMANCE ISSUES INCLUDED: 8 PATIENTS HAD NON-UNION, 14 PATIENTS HAD CAGE SUBSIDENCE, 8 PATIENTS HAD WEAKNESS AND 10 PATIENTS HAD NUMBNESS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

Additional Manufacturer Narrative

HTTPS://DOI.ORG/10.1007/S00586-025-09411 B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B.5. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. G2: COUNTRY OF EVENT IS AUSTRALIA 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.