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

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

Patient Problems Seroma (2069); Insufficient Information (4580)

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: d1, d2, d3, d4, g4 ¿ 510k: this report is for an unknown cage/spacer: eit - alif/unknown lot.Part and lot numbers are unknown; udi number is unknown.D9: complainant part is not expected to be returned for manufacturer review/investigation.E3: initial reporter is a synthes employee.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

This report is being filed after the review of a clinical evaluation report (cer) from a related research activity database (ddra) from premier healthcare database between january 1, 2019, and march 31, 2023, of patients who underwent stabilization procedures of the lumbar or lumbosacral spine using depuy spine conduit alif cages or depuy spine conduit llif cages (3d printed titanium cages previously known as eit cellular titanium alif and llif).131 patients were implanted with depuy spine conduit alif cages which consisted of 63 males and 68 females with a mean age 59 years.182 patients were implanted with depuy spine conduit llif cages which consisted of 64 males and 109 females with a mean age of 66 years.The complications as per icd 10 categorization identified in premier healthcare database were reported as follows: conduit alif cage (reoperation) 1 patient had reoperation due to seroma within 0-3 months post-index surgery.(revision) 3 patients had revision within 0-3 months post-index surgery.3 patients had revision within 4-6 months post index surgery.3 patients had revision within 7-12 months post-index surgery.1 patient had revision within 13-24 months post-index surgery.(reasons for revision) 4 patients had radiculopathy.1 patient had device-related complication.2 patients had pseudarthrosis.Conduit llif cage (revision) 1 patient had revision within 0-3 months post-index surgery.1 patient had revision within 4-6 months post index surgery.1 patient had revision within 7-12 months post-index surgery.(reason for revision) 2 patients had radiculopathy.A copy of the clinical evaluation form is being submitted with this regulatory report this report is for an unk cage/spacer: eit - alif this is report 1 of 3 for (b)(4).

• Brand Name: UNK CAGE/SPACER: EIT - ALIF
• 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 (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 18219922
• MDR Text Key: 329153431
• Report Number: 1526439-2023-02439
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• 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: 11/03/2023
• 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
• Patient Outcome(s): Required Intervention