MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK CONCORDE CAGE; INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR

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

Patient Problems Non-union Bone Fracture (2369); Osteolysis (2377); Post Operative Wound Infection (2446); Malunion of Bone (4529)

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cage/unknown lot.Part and lot numbers are unknown; udi number is unknown.Without a lot number the device history records review could not be completed.Product was not returned.The investigation could not be completed; no conclusion could be drawn, as no product was received.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: byvaltsev, v.A.Et al (2019), total arthroplasty and anterior cervical discectomy with fixation: long-term results of a randomized clinical trial, hirurgia pozvonochnika, vol.16 (1), pages 48¿56 (russia).The aim of this prospective randomized single-center cohort study was to perform a comparative analysis of the long-term outcomes of total cervical disc arthroplasty (cda) and anterior cervical discectomy and fusion in surgical treatment of patients with single-level degenerative diseases of cervical intervertebral discs.A total of 173 patients (109 male and 64 female) were included in the study.They were allocated into 2 groups: patients who had undergone total cda (84 patients; 51 male and 33 female; mean age = 42 years) or acdf (89 patients; 58 male and 31 female; mean age = 45 years).A total of 173 patients were independently sequentially allocated into groups (1:1) using software.Surgery was performed using concorde cage or competitor devices.Duration of the postoperative follow-up period was at least 48 months.The following complications were reported as follows: in the acdf group, a complete fusion was verified in 83 (93.3 %) cases.An unknown number of patients in the acdf group revealed a significantly higher degree of degenerative disease of superjacent intervertebral discs, while no significant degenerative changes were recorded in the subjacent discs.2 patients in the cda group and 8 patients (9%) in the acdf group had a symptomatic degeneration of adjacent segments, and they all underwent reoperations.3 cda patients had symptomatic adverse event effects in the form of heterotopic ossification.6 acdf patients had symptomatic adverse event effects in the form of pseudoarthrosis.3 cda patients had an intraoperative injury to vertebralis (n=1) or laryngeus recurrens (n=2).3 acdf patients had an intraoperative injury to laryngeus recurrens (n=1), esophagus (n=1) or dura mater (n=1).1 cda patient and 1 acdf patient had surgical site infection.1 acdf patient had lower extremity deep vein thrombosis, pulmonary embolism.This report is for an unknown depuy spine concorde cage.

• Brand Name: UNK CONCORDE CAGE
• Type of Device: INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÃ RL CH; chemin-blanc 38; le locle 02400 ; SZ 02400
• Manufacturer Contact: kara ditty-bovard ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 6103142063
• MDR Report Key: 12050032
• MDR Text Key: 262528483
• Report Number: 1526439-2021-01271
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/28/2021

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/23/2021
• 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
• Patient Outcome(s): Required Intervention