MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK USA, INC KYPHON XPEDE; CEMENT, BONE, VERTEBROPLASTY

Model Number MSB_UNK_BKP_CEMENT

Device Problem Leak/Splash (1354)

Patient Problem Extravasation (1842)

Event Date 04/16/2021

Event Type  malfunction  

Manufacturer Narrative

Mean age of 72 years (range 60-85 years).This value is the average age of the patients reported in the article as specific patients could not be identified.46 male and 52 female patients.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date of publication of the article or the date that the article was accepted for publication as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Jennifer l.Perez, alp ozpinar, nitin agarwal, emily hacker, nima alan and peter c.Gerszten: safety and efficacy of balloon kyphoplasty for vertebral fractures with posterior wall disruption.Int j spine surg 2021, 15 (2) 353-358 this study was performed to determine the safety as well as the efficacy of bk for vertebral body compression fractures associated with posterior wall disruption.This was a retrospective, nonrandomized clinical cohort investigation of patients with vcf and posterior wall disruption treated with bk between 2010 and 2018.From january 2010 to january 2018, 98 consecutive patients (157 vcf levels) who underwent a bk procedure in our hospital for unrelieved back pain from osteoporotic fractures and/or minor trauma leading to compression fractures were included in this study.All patients were aged 65 years and older and had fractures in the thoracic or lumbar vertebrae with preoperative computed tomography (ct)-confirmed posterior wall disruption and demonstrated evidence of vertebral body edema based upon magnetic resonance imaging (mri; acute or subacute fractures).Bipedicular access was obtained percutaneously in all cases.The kyphon express ii (medtronic spinal and biologics, memphis, tennessee) kit was used for all procedures.Balloons were inserted into the central anterior two-thirds of the vertebral body.Balloons were dilated appropriately and terminated when the balloon approached the subchondral plate.After balloon removal, high-viscosity barium-opacified pmma cement was infused ( kyphon xpede bone cement, medtronic spine llc, sunnyvale, california).Ninety-eight consecutive patients (52 [53%] female; 46 [47%] male) with 157 levels of bk were identified to fit the inclusion criteria.Mean body mass index (bmi) was 28.2 (68.3).Ninety-four levels were in the thoracic spine, and 63 were in the lumbar spine.Patients were divided into 2 groups: group 1 included those who underwent bk at levels t2¿l2 (121 levels), and group 2 included those who underwent bk at levels l3¿l5 (36 levels); this categorization is consistent with that performed in previous studies.17,18 the upper lumbar vertebrae (l1, l2) were grouped with the thoracic vertebrae, given their similarity in alignment with the thoracic spine.The results of this study are summarized below.In group 1, the mean avbh was 16.4 (64.4) mm preprocedure and 21.3 (65.3) mm postprocedure (p ¼.001).Mean vwa improved from 9.8 (64.9) to 4.7 (63.1).Mean preoperative kyphotic angle improved from 13.3 (610.6) to 8.8 (610.9).In group 2, the mean avbh was 24.6 (65.4) mm preprocedure and 26.5 (64.3) mm postprocedure (p¼.001; figure 5).Mean vwa improved from 3.6 (64.7) to 1.1 (65.4).Mean preoperative kyphotic angle improved from 11.5 (618.4) to 14.4 (616.5).Overall, in both groups 1 and 2, the mean vas improved from 8.7 preprocedure to 2.5 postprocedure (p ¼.001).Finally, there were 14 (9%) cases with asymptomatic cement leakage outside of the vertebral body.No patients developed new neurological symptoms after bk.In the current study, no patients experienced intraoperative pulmonary cement embolism.In the current study, 14 (9%) of patients experienced postoperative cement leakage.However, all cases of cement leakage were asymptomatic, and no patients experienced pulmonary cement embolism or any new neurological deficits.Ninety-eight consecutive patients with 157 vcf levels who underwent bk were evaluated.There was a significant improvement in anterior vertebral height, vertebral wedge angle, and local kyphotic angle in all cases.The mean preoperative vas improved from 8.7 preprocedure to 2.5 postprocedure (p¼.001).There were 14 (9%) cases with asymptomatic cement leakage outside of the vertebral body, and no patients experienced postprocedure neurological symptoms at the 6-week follow up.

• Brand Name: KYPHON XPEDE
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer (Section G): MEDTRONIC SOFAMOR DANEK USA, INC; 4340 swinea rd; memphis TN 38118
• Manufacturer Contact: tricha miles ; 1800 pyramid place; memphis, TN 38132 ; 7635140379
• MDR Report Key: 12039139
• MDR Text Key: 265802575
• Report Number: 1030489-2021-00824
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MSB_UNK_BKP_CEMENT
• Device Catalogue Number: MSB_UNK_BKP_CEMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 72 YR