BKP BALLOONS

Additional Manufacturer Narrative

ARTICLE CITATION INCLUDING WEB ADDRESS/LITERATURE REFERENCE (DOI): INOSE, HIROYUKI; TAKAHASHI, SHINJI; TERAGUCHI, MASATOSHI; KATO, TSUYOSHI; YAMADA, KENTARO; YASUDA, HIROYUKI; TERAKAWA, MASAKI; MINETAMA, MASAKAZU; TOMORI, MASAKI; NAKAGAWA, YUKIHIRO; YOSHII, TOSHITAKA HTTPS://DOI.ORG/10.1093/JBMRPL/ZIAE137 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B2: OUTCOME ATTRIBUTED TO ADVERSE EVENT IS FRACTURE. B3.PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION/ACCEPTANCE OF ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED ARTICLE. D4: PRODUCT IDENTIFIER IS UNKNOWN G4: PRODUCT IDENTIFIER IS UNKNOWN, HENCE 510K# IS NOT AVAILABLE. 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.

Description of Event or Problem

LITERATURE WAS REVIEWED REGARDING ROMOSOZUMAB VERSUS BISPHOSPHONATES FOR PREVENTING SUBSEQUENT VERTEBRAL FRACTURES AFTER BALLOON KYPHOPLASTY: COMPARISON USING DATA FROM TWO PROSPECTIVE MULTICENTER STUDIES. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: INTRODUCER INSTRUMENTS, INFLATABLE BONE TAMPS (BALLOONS), BONE CEMENT (PMMA ¿ POLYMETHYLM ETHACRYLATE) AND BONE CEMENT DELIVERY SYSTEMS. TOTAL 82 PATIENTS UNDERWENT STANDARD BALLOON KYPHOPLASTY USING INTRODUCER INSTRUMENTS, IBT'S, BONE CEMENT AND BONE CEMENT DELIVERY S YSTEMS, THE PATIENTS ADVERSE EVENTS INCLUDED: SUBSEQUENT VERTEBRAL FRACTURES AND HAD OSTEOPOROSIS PHARMACOLOGIC OUTCOMES. THE STUDY DOES NOT DESCRIBE ANY ISSUES, COMPLAINTS, OR ALLEGATIONS RELATED TO MEDTRONIC DEVICES. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.