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

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

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Date 07/25/2020

Event Type  Injury  

Manufacturer Narrative

Additional narrative: exact date of event is unknown; july 25, 2020 is the date the literature article was published.510k: this report is for unknown confidence spinal cement/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: mohammed r., (2020) vertebral body cemented stents combined with posterior stabilization in the surgical treatment of metastatic spinal cord compression of the thoracolumbar spine, surgical neurology international volume 11, pages 1-8 (united kingdom).This study aims to present the technique of posterior spinal decompression and stabilization coupled with vertebral body cemented stents and the preliminary results of this stabilization configuration which to our knowledge has not been reported before.14 patients (9 females, 5 males) who underwent posterior spinal decompression and pedicle screw construct along with vbs technique for posterior decompression is performed with laminectomy, flavectomy, and pedicle excision at the level of cord compression were analyzed.Vbs technique was performed using vertebral body stent (vbs, depuysynthes, switzerland).Once the anteroposterior and lateral fluoroscopy images show satisfactory stent expansion, the balloons are deflated and carefully extracted.Polymethyl methacrylate (pmma) cement injection delivery system is attached to the cannula.High-viscosity pmma cement (confidence spinal cement system® depuy synthes, usa) approved for use in vp/ kyphoplasty procedures is then injected into the void created within the stent under close monitoring of the lateral fluoroscopy.The following complications were reported as follows: five patients died at a mean 6.8 months (range 1¿15 months).While the remaining patients have a mean survival of 18 months.Two superficial wound infections required oral antibiotics and one of these unfortunately had wound dehiscence that needed plastic surgery input.This report is for an unknown depuy spine high-viscosity pmma cement (confidence spinal cement system).This is report 1 of 1 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• 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 ; SZ
• Manufacturer Contact: kara ditty-bovard ; 325 paramount drive; raynham, MA 02767 ; 6103142063
• MDR Report Key: 12468387
• MDR Text Key: 271480546
• Report Number: 1526439-2021-01993
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• 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?: 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: 08/17/2021
• 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