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 Injury (2348)

Event Date 02/08/2016

Event Type  Injury  

Manufacturer Narrative

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

This report is being filed after the review of the following journal article: balkarli, h., kilic, m., balkarli, a., and erdogan, m.(2016), an evaluation of the functional and radiological results of percutaneous vertebroplasty versus conservative treatment for acute symptomatic osteoporotic spinal fractures, injury, vol.47 (4), pages 865-871, https://www.Injuryjournal.Com/article/s0020-1383(16)00063-2/abstract (turkey).The aim of this retrospective study is to compare pvp and ct, which are two different treatment methods performed in acute ovf, in terms of effectivity, life quality, functionality, and radiological findings.Between march 2011 to january 2013, a total of 83 patients (25 male and 58 female) were included in the study.Percutaneous vertebroplasty (pv) was performed in 46 patients (15 male and 31 female) with a mean age of 73.8 ± 3.4 years, using depuy, confidence spinal cement system, while conservative treatment (ct) was performed in 37 patients (10 male and 27 female) with a mean age of 72.5 ± 4.3 years.The mean follow-up period of the patients was at least 6 months.The following complications were reported as follows: 4 patients had a cement leakage into the upper vertebral disc, and 2 patients into the lower vertebral disc.However, cement leakage did not create clinical symptom.This report is for an unknown depuy spine cement.A copy of the literature article is being submitted with this medwatch.This report is for one (1) unknown biomaterial - cement.This is report 4 of 6 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 (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: 10613899
• MDR Text Key: 209430124
• Report Number: 1526439-2020-01840
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 09/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 10/01/2020
• 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