MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNK - CAGE/SPACER: CONDUIT; INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR

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

Patient Problems Dysphagia/ Odynophagia (1815); Unspecified Infection (1930); Speech Disorder (4415); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559); Insufficient Information (4580)

Event Type  Injury  

Event Description

Device report from synthes reports an event in sweden as follows: this report is being submitted after a review of clinical evaluation report (cer) from a related research activity database (ddra) for 92 patients undergoing depuy spinal implants subreport 18-conduit cervical between january 02, 2006 and september 30, 2022.Of these cases, 3 were combined with a non-synthes anterior plate and were excluded, leaving 89 cases for analysis, including 50 cases combined with skyline.Mean age of patients was 51 years.Intra-operative complications were as follows: 1 case of dural injury.Post-operative complications were as follows: 2 cases of recurrent nerve injury, 1 case of infection, 1 case of thrombosis, 1 re-operation for adjustment of implant.This report involves one unk - cage/spacer: conduit.This is report 2 of 2 for (b)(4).

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.This report is for an unknown unk - cage/spacer: conduit/unknown lot.Part and lot numbers are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Initial reporter occupation: reporter is a j&j employee.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.

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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H10 additional narrative: b5, b7, h6.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

Updated event description.This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (drra): depuy spinal implants subreport 2024 - conduit cervical found in swedish spine registry (swespine).Instrumentation with conduit cervical was performed in 210 patients between 2018 and december 31, 2023.28 cases combined with anterior plate of non-depuy brand were excluded, leaving 182 cases for analysis, including 125 cases combined with skyline.Mean age of the patients was 51 years.The following complications were reported: intraoperative complications: (n=2) dural injury.(n=1) other.Postoperative complications within 1 year: (n=31) dysphagia.(n=19) vocal cord dysfunction.(n=3) infection.(n=1) thrombosis.Reoperations: (n=1) adjustment implant.(n=1) removal implant.(n=1) redecompression.(n=1) refusion.(n=1) other.This is for unknown depuy spine conduit and skyline for (b)(4).

• Brand Name: UNK - CAGE/SPACER: CONDUIT
• Type of Device: INTERVERTEBAL FUSION DEVICE W/BONE GRAFT, LUMBAR
• 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: kate karberg ; chemin-blanc 38; le locle ; SZ ; 3035526892
• MDR Report Key: 16609398
• MDR Text Key: 311958227
• Report Number: 1526439-2023-00582
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• 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
• Date Manufacturer Received: 03/11/2024
• 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