MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÃ RL CH UNKNOWN VERTEBRAL BODY REPLACEMENT - MESH; SURGICAL MESH

Catalog Number UNK VERTEBRAL BODY REPLACEMENT

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

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: d9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h4, h6: 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

Device report from synthes reports an event in japan as follows: it was reported that the patient underwent a removal surgery of implants on (b)(6) 2023 after an infection occurred.The implants had been placed on an unknown date at a different hospital.At the removal, symptoms seemed to have improved somewhat, and the patient was reported to be stable on (b)(6) 2023.As of (b)(6) 2023, it is still undecided whether to remove the infected vertebral body from the anterior side.The patient will be followed up.This report involves one unk vertebral body replacement - mesh.This report is related to (b)(4), which reports the screw involved in this event.This is report 1 of 1 for (b)(4).

• Brand Name: UNKNOWN VERTEBRAL BODY REPLACEMENT - MESH
• Type of Device: SURGICAL MESH
• 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: 17836383
• MDR Text Key: 324507201
• Report Number: 1526439-2023-01845
• Device Sequence Number: 1
• Product Code: EZX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK VERTEBRAL BODY REPLACEMENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2023
• 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
• Treatment: UNK - SCREWS: VIPER PRIME
• Patient Outcome(s): Required Intervention