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

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).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: d¿oria s, et al.(2021), traumatic compression fractures in thoracic-lumbar junction: vertebroplasty vs conservative management in a prospective controlled trial, j neurointervent surg, pages 1-6, (italy).This article aims to compare the outcomes of conservative management to those of vertebroplasty, a relatively safe and simple procedure.Between january 2012 and february 2016, 102 patients presenting with a single-level, post-traumatic a1 or a2 mager l type fracture, affecting the thoracic-lumbar spine without any neurological deficits were included in the study.After description of both treatment options, the patients were asked to choose between vertebroplasty or conservative treatment.Accordingly, the patients were allocated into two groups.The first group (group a) included 52 patients (30 males, mean age of 46.6 years), treated with bed rest for 2 weeks then were gradually mobilized and had to wear a brace with 3 support points (tlso brace) when standing or sitting for a further 4 weeks.The second group (group b) of 50 patients (25 males, mean age of 44.3 years) underwent a percutaneous vertebroplasty.Treatment was performed at an average 2.3 days after the trauma (range 1¿4) and patients were kept on bed rest prior to it.All surgery treatments were carried out using the kit ¿unknown depuy spine confidence spinal cement system¿.Patients were then mobilized as early as 6 hours after the procedure unless the residual pain did not allow it.Complications were reported as follows: 16 patients had leakage of cement into the adjoining disc space, the paravertebral space, or into a vein.In all cases the cement leakage was clinically silent: there were no further surgical or medical complications among the operated patients.This report is for the unknown depuy spine confidence spinal cement system.

• 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 (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: 11914388
• MDR Text Key: 265282050
• Report Number: 1526439-2021-01074
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• 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: 05/04/2021
• 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