MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - BIOMATERIAL - CEMENT: CONFIDENCE; CEMENT, BONE, VERTEBROPLASTY

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown confidence cement/ unknown lot.Part and lot number are unknown.Without the specific part number; the udi number and 510-k number is unknown.Complainant part is not expected to be returned for manufacturer review/ investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the review of the following journal article: minghui l., yang l., mi z., feng x., (2019) percutaneous vertebroplasty with different viscosities of bone cement for treatment of thoracolumbar metastases, zhongguo zuzhi gongcheng yanju volume 23 (26), pages 4129-4135 (china).This a randomized controlled study aims to compare their clinical efficacy and complications of the use of high viscosity or low viscosity bone cement for vertebroplasty.From june 2012 to october 2017, 101 patients with spinal metastases of malignant tumors admitted in department of orthopedics, the second affiliated hospital of jianghan university, were included in the study.These patients were randomly divided into two groups according to the random number table method.In the observation group, there were 49 patients, including 27 males and 22 females, ages 52-87 years (average 63.4 years), and a total of 103 vertebral bodies (64 thoracic vertebrae and 39 lumbar vertebrae) were treated using confidence high viscosity bone cement for vertebroplasty; and in the control group, there were 52 patients, including 29 males and 23 females, ages 52-83 years (average 62.7 years), and a total of 107 vertebral bodies (70 thoracic vertebrae and 37 lumbar vertebrae) were treated using heraeus low viscosity bone cement for vertebroplasty.The vertebroplasty operating system was a product made by zhongshan shiyitang medical equipment co., ltd.In china, and the biopsy puncture awl was a product made by suzhou and science & technology development corporation.Patient were followed up for 3-30 months, with an average of 18 months.The following complications were reported as follows: 72 patients died of primary diseases, including 7 deaths within 3-6 months, 12 deaths within 6-12 months, 19 deaths within 12-18 months, 21 deaths within 18-24 months and 13 deaths within 24-30 months.It was found in the postoperative imaging examination of 103 vertebral bodies in the observation group that leakage occurred around 17 vertebral bodies, with a leakage rate of 16.50%.Among them: 5 vertebral bodies had simple paravertebral soft tissue leakage, 3 had simple intervertebral disc leakage, 3 had simple paravertebral vein leakage, 1 had simple pedicle leakage, 2 had intraspinal leakage (1 had leakage in the thoracic vertebra, and the patient had no neurological symptoms; and 1 had leakage in the lumbar spine, and after the operation, there was soreness and pain of the lower limbs, and the symptoms were relieved after oral administration of non-steroidal anti-inflammatory drugs and mannitol dehydration treatment for 1 week).Leakage in the other 3 vertebral bodies was mixed leakage (occurrence of paravertebral soft tissue leakage and paravertebral vein or intervertebral disc leakage).Figure 2.Imaging photos of a female (b)(6) year-old patient with bone metastases of pulmonary cancer before and after treatment shows the posteroanterior and orthotopic x-ray of high viscosity bone cement vertebroplasty, with a low amount of bone cement leakage seen in the spinal canal and paravertebral vein, and with the patient having no neurological symptoms; panel d shows the preoperative magnetic resonance examination after half a year at the second admission, suggesting new bone metastases to t3, t9 and l1; panel e and f show the posteroanterior and orthotopic x-ray of high viscosity bone cement vertebroplasty, with a low amount of bone cement leakage seen at the posterior border of the vertebral body and the paravertebral vein.This report is for an unknown depuy spine confidence cement.This is report 1 of 2 for (b)(4).

• Brand Name: UNK - BIOMATERIAL - CEMENT: CONFIDENCE
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer (Section G): MEDOS INT SPINE; chemin blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12573098
• MDR Text Key: 274740465
• Report Number: 1526439-2021-02104
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention