MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH EIT PLIF, H 9MM, 8°, 26/9; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Catalog Number	PUI80906
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during an interbody fusion (l2-3) procedure for stenosis, the cage was filled with bones, placed on the inserter, and inserted into the interbody space.The cage could not be removed despite multiple attempts over 10 minutes, requiring removal from the body with significant force.After reinsertion, the cage again could not be detached in the interbody, resulting in approximately a 30-minute surgical delay.The cage was then replaced with another device, which functioned as intended.The surgery was completed successfully.

• Brand Name: EIT PLIF, H 9MM, 8°, 26/9
• 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): SYNTHES SELZACH; bohackerweg 5; selzach MA ; SZ
• Manufacturer Contact: barbara wirth ; eisenbahnstrasse 84; wurmlingen D-785-73 ; GM D-78573 ; 6103142063
• MDR Report Key: 25104801
• Report Number: 3013730328-2026-00014
• Device Sequence Number: 10756769
• Product Code: MAX
• UDI-Device Identifier: 04260557779965
• UDI-Public: (01)04260557779965(17)341231(10)152890
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: PUI80906
• Device Lot Number: 152890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/22/2026
• Supplement Date Received by Manufacturer: 05/19/2026; 06/04/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/20/2026; 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2025
• 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
• Patient Sex: Unknown