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

Model Number MSB_UNK_BKP_CEMENT

Device Problem Leak/Splash (1354)

Patient Problems Extravasation (1842); Hematoma (1884); Muscular Rigidity (1968); Pain (1994); Numbness (2415); Thrombosis/Thrombus (4440); Swelling/ Edema (4577)

Event Date 01/01/2023

Event Type  Injury  

Event Description

Summary: a 68-year-old woman, with a history of lumbar spondylosis and herniated intervertebral discs of l2-5 with bilateral radiculopathy, received bilateral lamino-facetectomy of l2-4, microdiscectomy and interbody fusion with cages of l2-3, l3-4, and l4-5, internal fixation with pedicle screws of l2-5, vertebroplasty with bone cement via the pedicle screws of l2-5, and posterolateral fusion with allograft and autologous bone of l2-5, on the (b)(6) 2020.Postoperative lumbar spine anterior-posterior and lateral radiograph views showed disc implants and transpedicular screws, cement drainage from the paravertebral venous plexus, and a long segment of cement over the righthand side of vertebral body.She complained of tightness of both legs and numbness of left toes 6 months after vertebroplasty.She had pain extending from lower back to bilateral thighs, and bilateral legs swelling.A venogram and computed tomography scan showed left psoas muscle hematoma, a cement in the inferior vena cava (ivc) with thrombus below the level of the left renal vein, and cement draining through the paravertebral venous plexus to the ivc with thrombosis at the cement-injected l4 vertebral body level (figure 1), thrombosis of the ivc from the level of the renal veins to bilateral common iliac veins, and partial thrombosis of bilateral superficial femoral veins with collateral circulation from the bilateral ovarian veins to the bilateral renal veins with dilatation.Intravenous heparinization was administered.However, her left leg swelling worsened day by day.Intravascular ultrasound revealed a spiral hyperechoic foreign body within the ivc above the renal level and thrombosis around the foreign body below the renal level.Mechanical thrombectomy was performed for thrombo-aspiration,which retrieved massive thrombi.

Manufacturer Narrative

Date of event: 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.510(k) is unknown.Rei-yeuh chang, md, ms; tsung-hsien chen, phd; chu-jen kuo, md; han-lin tsai, md.Intravascular ultrasound and multidetector computed tomography imaging of polymethylmethacrylate cement leakage inducing inferior vena cava thrombosis.Circulation: cardiovascular imaging.Circ cardiovasc imaging.2023;16:e014527.Doi: 10.1161/circimaging.122.014527.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: BKP CEMENT
• 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: glen belmer ; 1800 pyramid place; memphis, TN 38132 ; 6122713209
• MDR Report Key: 16441762
• MDR Text Key: 310229038
• Report Number: 1030489-2023-00115
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• Is this an Adverse Event Report?: Yes
• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Female