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

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 biomaterial - cement/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

Device report from synthes reports an event in (b)(6) as follows: this report is being filed after the review of the following journal article: lubansu, a.Et al.(2012), minimally invasive spinal arthrodesis in osteoporotic population using a cannulated and fenestrated augmented screw: technical description and clinical experience, minimally invasive surgery, volume 2012, pages 1-11 (belgium).The purpose of this paper is to describe a novel technique using cannulated and fenestrated pmma augmentable screw in percutaneous and minimally invasive spinal posterior arthrodesis and to report the safety and efficiency of this technique in a prospective patient series.Between march 2010 and july 2011, 15 patients (12 female, 3 male, mean age 71.2 years (60¿88)) with osteoporotic compression/burst fracture (4 patients), degenerative spondylolisthesis (5 patients), and spinal and/or foraminal stenosis (6 patients) underwent mis posterior pedicle arthrodesis with or without interbody fusion with pmma cement augmentation of pedicle screws.The novel pedicle screw used in this series was the titanium expedium fenestrated screw (viper mis spine system, depuy spine, johnson & johnson) which is a polyaxial and fully cannulated screw with six fenestrations in the grooves of the distal portion of the thread and an opening at the distal tip.Pmma bone cement (vertebroplastic, depuy spine, johnson & johnson) was extruded through the fenestrations to fill the spaces inside the osteoporotic cancellous bone.All patients were followed up at the outpatient department at 3, 6, and 12 months, and then regularly every year.The following complications were reported as follows: a (b)(6) female patient had transient radiculitis, screw misplacement.A (b)(6) femalte patient had asymptomatic lateral external venous plexus pmma extravasation (screw related).An (b)(6) male patient had asymptomatic lateral external venous plexus pmma extravasation (screw related).A (b)(6) male patient had asymptomatic posterior leakage pmma extravasation (screw related) and subcutaneous infection.A (b)(6) female patient had asymptomatic intradiscal pmma extravasation (screw related).A (b)(6) female patient had asymptomatic posterior leakage pmma extravasation.This report is for unknown biomaterial, cement.This is report 3 of 7 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.D1 - brand name.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 for one (1) unk - biomaterial - cement: vertebroplastic.

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.H3, h6: the investigation could not be completed.No conclusion could be drawn, as no product was received.Product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.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.

• Brand Name: UNK - BIOMATERIAL - CEMENT: VERTEBROPLASTIC
• Type of Device: POLYMETHYLMETHACRYLATE BONE CEMENT
• 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 ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12452873
• MDR Text Key: 270795373
• Report Number: 1526439-2021-01917
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• 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: 11/01/2021
• 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