MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH EIT TLIF, H 10MM, 12°, 32/12; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	TUI31032
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	09/21/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint#: (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.H11 additional narrative: h6 health effect clinical code: e2015 is used to capture dural tear.
Event or Problem Description
Study no: (b)(4).Subject id: (b)(6).Clinical adverse event received for durotomy: severity: mild, is the adverse event serious? no, relationship to study device: not related relationship to primary study procedure: not related, outcome: recovered/resolved, date of event: 21 sep 2022, date of implant: on (b)(6) 2022, date of revision: no information provided, device location: l2-l3, l3-l4, l4-l5.Treatment/impact: surgical intervention not for the study spine segment, specify: l3 treated with muscle plug and tisseel l3-4 treated with 6-0 gore-tex and muscle plug, tisseel.Date of surgical intervention: on (b)(6) 2022.
Additional Manufacturer Narrative
Additional information has been received; the previously reported event is no longer considered reportable at this time as there was no failure of the device.No further follow-ups will be sent.

• Brand Name: EIT TLIF, H 10MM, 12°, 32/12
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73; GM D-78573
• Manufacturer (Section G): EIT EMERGING IMPLANT TECHNOLOGIES GMBH
• Manufacturer Contact: barbara wirth ; eisenbahnstrasse 84; wurmlingen D-785-73 ; GM D-78573 ; 74611716904
• MDR Report Key: 22070419
• Report Number: 3013730328-2025-00025
• Device Sequence Number: 8701977
• Product Code: MAX
• UDI-Device Identifier: 04260557776797
• UDI-Public: (01)04260557776797(17)260531(10)E21LA0232
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K172888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,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 Expiration Date: 05/31/2026
• Device Catalogue Number: TUI31032
• Device Lot Number: E21LA0232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 05/19/2025
• Initial Report FDA Received Date: 05/22/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female