MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH EIT CIF CAGE, H 7MM, 4°, S; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Catalog Number	CUI4070S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	03/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2024, the original operation took place.The patient returned to office for routine follow-up as well as review of lumbar spine for surgical intervention.The screw back out was noticed on follow-up x-rays.Surgeon determined at the time he would remove the screw on the same day the patient was having a posterior lumbar fusion completed.Revision was performed.Coda 48mm plate was originally implanted with 3.5x16 screws in c7.There was bilateral flange breakage over c7 screws.Removed c7 screws.Both screws were broken and tips of screws remained in the vertebral body.Upon review of the construct, the surgeon determined the plate was not remaining flush with the vertebral bodies which indicated potential movement at the adjacent levels.He made the decision to remove the plate and replace it with skyline to avoid additional screw/plate breakage of the existing coda plate.Surgeon manually attached removal tool to cage at each level and determined there was no cage loosening at c4/5, c5/c6.Cage at c6/c7 appeared to show signs of nonunion prompting surgeon to remove the 7mm 4* conduit cage.A new conduit 9mm 8* packed with vivigen was placed in the c6/c7 disc space.A 48mm skyline plate was placed.Final images taken to confirm position of revision hardware.All cam mechanisms were final tightened with an audible click from reaching torque limit as well as visual confirmation showing locks rotated to interface with screws.Specimen was taken from c7 screw holes to rule out infection.Other medical intervention included intraoperative x-rays and preop cts.
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.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.
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.H3, h6: 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.

• Brand Name: EIT CIF CAGE, H 7MM, 4°, S
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL
• Manufacturer (Section D): EIT EMERGING IMPLANT TECHNOLOGIES GMBH; eisenbahnstrasse 84; wurmlingen D-785 73
• Manufacturer Contact: barbara wirth ; eisenbahnstrasse 84; wurmlingen D-785-73 ; GM D-78573 ; 74611716904
• MDR Report Key: 21719124
• Report Number: 3013730328-2025-00018
• Device Sequence Number: 11760703
• Product Code: ODP
• UDI-Device Identifier: 04260557770306
• UDI-Public: (01)04260557770306
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K172888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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: CUI4070S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 06/18/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 3 LEVEL PLATE 48MM; VARIABLE SELF DRILLING 3.5X14; VARIABLE SELF DRILLING 3.5X16
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 73 KG