MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN BIOMATERIAL - CEMENT; POLYMETHYLMETHACRYLATE BONE CEMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

There are multiple patients all information is provided in the article.This report is for an unknown biomaterial - cement/unknown lot.Part and lot number are unknown; udi number is unknown.Implant date is between january 2006 to december 2015.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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: semaan, h.Et al (2018), clinical outcome and subsequent sequelae of cement extravasation after percutaneous kyphoplasty and vertebroplasty: a comparative review, acta radiologica, vol.59 (7), pages 861-868, doi: 10.1177/0284185117732599 (usa).The aim of this retrospective consecutive case series study is to identify the sites and incidence rates of cement extravasation after percutaneous kyphoplasty and vertebroplasty, and to evaluate their impacts on the clinical outcomes and the subsequent sequelae.Between january 2006 to december 2015, a total of 316 patients (61 male and 255 female) with a mean age of 74.3 years (range = 24-102 years) were included in the study.The total number of cases/levels included in this study was 411 (223 kyphoplasty and 188 vertebroplasty).Of these, only 61 patients who underwent vertebroplasty was performed with confidence spinal cement system.Follow-up period was a minimum of 12 months.The following complications were reported as follows: according to the fracture types, 103/329 vertebrae (31.3%) of the osteoporotic compression fractures and 40/82 vertebrae (48.8%) of the pathologic fractures had cement extravasation.81/188 vertebrae (43.1%) in the vertebroplasty group had cement extravasation; six of them had extravasation at two sites.In 26/81 cement-leaked cases (32.1%) in the vertebroplasty group (188 cases) had intradiscal extravasation.3/26 vertebrae had adjacent vertebral fractures in the vertebroplasty subgroup.This report is for an unknown confidence spine cement system.This report is for one unk biomaterial - cement.This is report 2 of 2 for (b)(4).

• Brand Name: UNKNOWN BIOMATERIAL - CEMENT
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 9480465
• MDR Text Key: 188551395
• Report Number: 1526439-2019-52695
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2019
• 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