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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: this report is for an unknown confidence spinal cement system/unknown lot.Part and lot number are unknown; udi 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: lin t-y, et al.(2021), cement augmentation for single-level osteoporotic vertebral compression fracture: comparison of vertebroplasty with high-viscosity cement and kyphoplasty, world neurosurg, volume141, pages e266-e270, (taiwan).The purpose of this study was to compare the clinical effects between highly viscous cement vertebroplasty and kyphoplasty in the treatment of single-level osteoporotic vertebral compression fractures including radiographic and clinical outcomes.From january 2017 to october 2018, 96 patients with single-level osteoporotic vertebral compression fracture who had undergone either highly viscous cement vertebroplasty (hvc) or kyphoplasty (kp) surgery with at least 1 year follow-up were included in the study.Patients were divided into the hvc group (50 patients) or the kp group (46 patients).In the hvc group, there were 35 women and 15 men (mean age: 76.3 +/- 9.2 years).In the kp group, there were 35 women and 11 men (mean age, 74.93 +/- 7.38 years).All patients were treated with the depuy spine confidence spinal cement system.The hvc and kp procedures were then performed.The volume of injected cement depended on the bone defect and individual patient's condition.Complications were reported as follows: hvc group 11 patients had mild cement leakage.7 patients had adjacent fracture after 1 year of follow-up.Kp group.8 patients had mild cement leakage.8 patients had adjacent fracture after 1 year of follow-up.This report is for the unknown depuy spine confidence spinal cement system.This is report 1 of 1 for (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.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.

• 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
• MDR Report Key: 12468796
• MDR Text Key: 271310078
• Report Number: 1526439-2021-02003
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/05/2021
• Patient Sequence Number: 1