MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH LLIF UI H 8MM 8DEG 50/18; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	LUI80849
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Paralysis (1997)
Date of Event	02/20/2026
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 manufacturer narrative: d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Event or Problem Description
It was reported that this was an oblique lateral interbody fusion(l3-l4) performed on (b)(6) 2026.During the surgery, the cage was placed further back than usual, but the wound was closed by the surgeon¿s decision.After the surgery, the paralysis on the patient¿s leg was confirmed.The reoperation to replace further forward than primary surgery the cage, the operation was completed successfully with 120 minutes surgical delay.The patient's condition after the surgery is unknown.
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.H11 additional narrative: h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.Investigation summary- product was not returned.Based on the information available, it has been determined that no corrective and 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 if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LLIF UI H 8MM 8DEG 50/18
• 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 (Section G): MEDOS INT SPINE; chemin blanc 38; le locle ; SZ
• Manufacturer Contact: barbara wirth ; eisenbahnstrasse 84; wurmlingen D-785-73 ; GM D-78573 ; 74611716904
• MDR Report Key: 24519981
• Report Number: 3013730328-2026-00011
• Device Sequence Number: 9759119
• Product Code: MAX
• UDI-Device Identifier: 04260557834725
• UDI-Public: (01)04260557834725
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K181644
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: LUI80849
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Sex: Unknown