MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH EIT TLIF CAGE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	TUI81428
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Dural Tear (1417)
Date of Event	05/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint#: (b)(4).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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Subject id: (b)(6).Study no: (b)(4).Clinical adverse event received for incidental durotomy repaired during procedure device related: not related, procedure related: probable, date of event: 19 may 2026, date of implant: on (b)(6) 2026, date of revision: no information provided.Device location: l4-l5: yes.Treatment/impact: surgical intervention for the study spine segment (on (b)(6) 2026), depuy synthes products used: catalog number: tui81428, lot number: no information provided, component type: cage, description: eit tlif, h 14mm, 8°, 28/10, catalog number: unk - screws, lot number: no information provided, component type: pedicle screws, description: expedium verse(r) spinal system pedicle screws, catalog number: unk - rods, lot number: no information provided, component type: rods, description: expedium verse(r) spinal system rods.
Additional 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.H11 additional narrative: investigation summary an analysis of the product could not be performed since a physical sample was not received for evaluation.The ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer as part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition, therefore it has been determined that no corrective and preventive action is required at this time.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of the post-market surveillance.However, if the product is received at a later date, the investigation will be updated as applicable.Device history lot a review of the receiving inspection (ri) for tlif-c ui 14mm 8deg 28/10, was conducted identifying that lot number 455078, was released in one batch.Batch1: lot qty of (b)(4) units were released on sep 9, 2025 with no discrepancies.Supplier : (b)(4).As a result, the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.Device history review the ri identified no issues during the manufacturing and release of this device that could have contributed to the problem reported by the customer.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: EIT TLIF CAGE
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 25505810
• Report Number: 3013730328-2026-00017
• Device Sequence Number: 10506153
• Product Code: MAX
• UDI-Device Identifier: 04260557776469
• UDI-Public: (01)04260557776469(17)350831(10)162771
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup

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
• Operator of Device: Health Professional
• Device Catalogue Number: TUI81428
• Device Lot Number: 162771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/21/2026
• Supplement Date Received by Manufacturer: 06/16/2026; 06/27/2026
• Initial Report FDA Received Date: 06/15/2026
• Supplement Report FDA Received Date: 06/24/2026; 06/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN RODS; UNKNOWN SCREWS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown