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

Catalog Number UNK - CAGE/SPACER: BRANTIGAN

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

Patient Problems Dysphagia/ Odynophagia (1815); Nerve Damage (1979); Osteolysis (2377)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

This report is for an unknown cage/spacer/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: donk r., et al(2017) what's the best surgical treatment for patients with cervical radiculopathy due to single-level degenerative disease? a randomized controlled trial, plos one volume 12(8), pages 1-17 (netherland).This study aims to investigate whether the patient-reported clinical outcome differed between patients who were treated by either acd, acdf with cage stand-alone, or acda.Between october 5th, 2003 and june 10th 2010, patients were enrolled in a single center (the canisius wilhelmina hospital, department of neurosurgery, nijmegen, the netherlands) in a randomized controlled trial.Overall, 272 patients were eligible for inclusion in the trial after screening.The mean age of the study population was 44.9±6.5 years; 50% were female.However, 18 patients explicitly had a clear preference for one treatment, and 112 refused to participate.Finally, 142 patients gave informed consent and were randomized.Patients were assigned to surgical treatment consisting of cervical anterior discectomy followed by one of the following three surgical options: fusion by cage stand-alone (acdf) (brantigan cervical i/f cage, depuy spine, inc., raynham, ma, usa) filled with autologous bone, arthroplasty (acda) where a bryan disk prosthesis (bryan disk prosthesis, medtronic, memphis, tn, usa) was implanted, or no implant at all (acd).Fifty patients were allocated to acda, 47 to acdf, and 45 to acd.One patient was allocated to the arthroplasty group, but intraoperatively it was not possible to introduce the disk prosthesis and a cage was implanted instead.This patient remained within the arthroplasty group for analysis.Postoperative data collection started 6 weeks postoperatively, and patients were followed for 5 years.At the last follow-up, patients were also asked to complete nrs arm and nrs neck questionnaires estimating the pain during the previous 24 hours.The median follow-up was 8.9±1.9 years (5.6 to 12.2 years).The following complications were reported as follows: one patient allocated to acda died due to a cause unrelated to the intervention.Fusion by cage stand-alone (acdf): 1 superficial wound infection.1 hoarseness.4 dysphagia.Surgery for recurrent signs and symptoms due to nerve root compression at the index level or adjacent segment.5 surgery for adjacent segment disease.1 surgery for recurrent compression at the index level.Acda: 2 dysphagia.1 surgery for recurrent compression at the index level.This report is for an unknown depuy spine brantigan cage.

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.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 - CAGE/SPACER: BRANTIGAN
• 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
• MDR Report Key: 11968896
• MDR Text Key: 265802047
• Report Number: 1526439-2021-01197
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 05/17/2021

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
• Device Catalogue Number: UNK - CAGE/SPACER: BRANTIGAN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 09/23/2021
• Supplement Dates FDA Received: 09/24/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention