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

Catalog Number UNK BIOMATERIAL - CEMENT

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

Patient Problems Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Neurological Deficit/Dysfunction (1982); Pain (1994); Weakness (2145); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Product complaint #: (b)(4).510k: this report is for an unknown biomaterial - cement/unknown lot number.Without the specific part number, the udi number and 510k 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 as no product was received.Investigation summary: 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, 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.(b)(4).

Event Description

This report is being filed after the review of the following journal article: rustagi, t.Et al (2020), transpedicular vertebrectomy with circumferential spinal cord decompression qnd reconstruction for thoracic spine metastasis: a consecutive case series, spine an international journal for the study of the spine, vol.Xx (xx), pages 1-25 (usa).The aim of this retrospective study is to study the feasibility, outcomes and complications of transpedicular vertebrectomy (tpv) and reconstruction for metastatic lesions to the thoracic spine.Between january 2008 to december 2016, a total of 96 patients (48 male and 48 female) with a mean age of 60 years (iqr: 51-65 years) underwent transpedicular vertebrectomy (tpv).Reconstruction of the anterior column following vertebrectomy was performed using pmma cement in 78 patients and titanium cage in 18 patients.Cement reconstruction was performed using confidence® (depuy, raynham, ma).The follow-up period was unknown.The following complications were reported as follows: total 59 deaths were observed.The median survival time was estimated to be 6 months (95% ci: 5, 10).3 patients died within 30 days.3 patients (cage) and 7 patients (cement) had operative complications.7 patients (cage) and 20 patients (cement) had postoperative complications.6 patients had a durotomy/csf leak.3 patients had a superficial infection.1 patient had a pleural tear.4 patients had pneumonia.3 patients had a urinary infection.3 patients had deep venous thromboses (dvt).2 patients developed progressive weakness in the immediate postoperative period due to epidural hematoma, requiring emergent hematoma evacuation; neurological function returned to baseline in both cases.1 patient was reintubated.1 patient had stroke.In most cases, frankel grade did not change following surgery (figure 3).Of the 18 cases, where change was seen, 16 (88.8%) improved by at least one grade.In two cases, patients deteriorated from frankel e to d (wound hematoma).1 patient had instrumentation failure from cement/cage migration, needing revision (figure 2a-c).This report is for an unknown depuy spine confidence cement.This impacted product captures the following adverse events: operative/postoperative complications.Durotomy/csf leak.Superficial infection.Pleural tear.Pneumonia.Urinary infection.Deep venous thromboses (dvt).Progressive weakness due to epidural hematoma.Reintubated.Stroke.No change/deteriorated of frankel grade.This report is for one (1) unknown biomaterial - cement.This report is 1 of 2 for (b)(4).A copy of the literature article is being submitted with this medwatch.

• 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: 10113266
• MDR Text Key: 194150961
• Report Number: 1526439-2020-01107
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK BIOMATERIAL - CEMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2020
• 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