BKP BALLOONS

Description of Event or Problem

INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER, LITERATURE ARTICLE) REGARDING A PATIENT HAVING SPINAL THERAPY. LITERATURE WAS REVIEWED REGARDING RELATIONSHIP OF PREEXISTING VERTEBRAL FRACTURES AND ENDPLATE INJURY TO INTERVERTEBRAL BRIDGING OSSIFICATION AFTER BALLOON KYPHOPLASTY FOR OSTEOPOROTIC VERTEBRAL FRACTURES. THE FOLLOWING MEDTRONIC DEVICES WERE USED: TOTAL 134 PATIENTS INCLUDED IN THE FINAL ANALYSIS UNDERWENT BALLOON KYPHOPLASTY USING INFLATABLE BONE TAMPS (IBT), POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT AND CEMENT DELIVERY INSTRUMENTS. AMONG ALL BALLOON KYPHOPLASTY DEVICES USED, THE PATIENTS REPORTED WITH THE FOLLOWING ADVERSE EVENTS POST SURGERY: IN THE RETROSPECTIVE CLINICAL STUDY EVALUATING BALLOON KYPHOPLASTY (BKP) FOR OSTEOPOROTIC VERTEBRAL FRACTURES, SEVERAL POSTOPERATIVE CLINICAL AND RADIOGRAPHIC EVENTS WERE REPORTED DURING FOLLOW-UP. THE PRIMARY REPORTED EVENT WAS INTERVERTEBRAL BRIDGING OSSIFICATION (IBO), WHICH OCCURRED IN 36 OF 134 PATIENTS (26.9%). PATIENTS WHO DEVELOPED IBO EXPERIENCED HIGHER LEVELS OF BACK PAIN DURING THE EARLY POSTOPERATIVE PERIOD (APPROXIMATELY ONE MONTH) COMPARED WITH THOSE WITHOUT IBO, ALTHOUGH PAIN AND FUNCTIONAL OUTCOMES WERE SIMILAR BETWEEN GROUPS AT ONE YEAR. IN ADDITION, THE STUDY REPORTED THE OCCURRENCE OF ADJACENT VERTEBRAL FRACTURES DURING FOLLOW-UP, WHICH WERE OBSERVED MORE FREQUENTLY IN THE IBO GROUP AND WERE ASSOCIATED WITH POSTOPERATIVE PAIN IN SOME CASES. THE STUDY DID NOT REPORT DEVICE MALFUNCTION, CEMENT LEAKAGE¿RELATED COMPLICATIONS, NEUROLOGICAL INJURY, INFECTION, OR OTHER PROCEDURAL COMPLICATIONS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

Additional Manufacturer Narrative

ARTICLE CITATION INCLUDING WEB ADDRESS/LITERATURE REFERENCE (DOI): TOSHIAKI MARUYAMA, NAOSUKE KAMEI, TOSHIO NAKAMAE, YOSHINORI FUJIMOTO, KIYOTAKA YAMADA, KAZUTO NAKAO, FADLYANSYAH FARID, HIROKI FUKUI AND NOBUO ADACHI HTTPS://DOI.ORG/10.1155/JOOS/1886674 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 ACCEPTANCE OF ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED ARTICLE. D1, D2 <(>&<)> 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.