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Model Number KY_UNK_BKP_IBT |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 07/30/2021 |
Event Type
Injury
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Manufacturer Narrative
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Age: this value is the average age of the patients reported in the article as specific patients could not be identified.Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Event date: please note that this date is based off of the date of publication of article as the event dates were not provided in the published article.Product identifier is unknown, product identifier is unknown, hence 510k# is not available.Noritaka yonezawa, yoshiro yonezawa, tatsuya nishimura, teruhisa yamashiro, kengo shimozaki, akari mori,satoru demura, hiroyuki tsuchiya vertebra-pediculoplasty: a new approach to treatment of split-type and delayed-union osteoporotic vertebral fracture with a risk of cement dislodgement.Doi.10.1016.2021.07.142.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Summary: the clinical outcomes of balloon kyphoplasty (bkp) for split-type osteoporotic vertebral fractures (ovf) are poor.These may be owing to the vertebral body bifurcating anteriorly and posteriorly when a load is applied and the filled cement being unstable.We report the usefulness of bkp combined with pediculoplasty using cannulated screws (vertebrapediculoplasty) for ovf with a risk of cement dislodgement.Between april 2020 and february 2021, this surgery was performed on 10 patients with split-type and delayed-union ovf.The diagnosis was made using imaging findings on preoperative computed tomography or intraoperative images during balloon inflation.Early postoperative ambulatory rehabilitation was performed, and clinical outcomes were evaluated.Early pain relief was obtained in all patients.The stability of the fractured vertebrae was demonstrated using both supine and seated radiographs from the early postoperative period, and good clinical results were obtained.The cement in this surgery was stabilized using a cannulated screw in the vertebral body, anteroposteriorly, and craniocaudally.The cement mass integrated with the cannulated screw was stabilized with the vertebral lamina and pedicle as a stopper.Vertebra-pediculoplasty could be an effective method for managing ovf with a high risk of cement dislodgement, which has been difficult to treat using conventional bkp.Reported event: the surgical outcome of 10 patients who underwent bkp combined with pediculoplasty using cannulated screws.In all patients, cement stability in the affected vertebra was achieved until the final follow-up with no screw-related complications.The mean follow-up time was 9 months (range,3e13 months).In 3 patients (cases 3, 6, and 9), acute adjacent secondary vertebral fracture occurred, and in 2 cases, a second bkp was performed, and the other case was treated conservatively.Low back pain improved in all patients after surgery at the final follow-up.There were no complications associated with neural deficits, and ambulatory status was maintained in all patients at the final follow-up.Complete bone union of the affected vertebra was achieved in 8 patients, and almost complete fusion of the bones and massive bridging callus was observed at the final follow-up in the remaining 2 patients.
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