MAUDE Adverse Event Report: SYNTHES GMBH UNK - SYNFLATE/VBS; SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: this report is for an unk: synflate/vbs/unknown lot.Part and lot numbers 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.There were no procedural stent-related issues except in three cases were the stent failed to fully inflate.This report is for an unknown depuy synthes vertebral body stent (vbs).This report is for one (1) unk - synflate/vbs.This is report 2 of 2 for complaint (b)(4).

• Brand Name: UNK - SYNFLATE/VBS
• Type of Device: SPINAL VERTEBRAL BODY REPLACEMENT DEVICE
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 12480704
• MDR Text Key: 271674688
• Report Number: 8030965-2021-07724
• Device Sequence Number: 1
• Product Code: MQP
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• 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: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1