MAUDE Adverse Event Report: EIT EMERGING IMPLANT TECHNOLOGIES GMBH CIF UI H 7MM 8DEG S; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

Catalog Number	CUI8070S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	10/01/2025
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.Additional narrative: 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 wound drainage device and procedure (relatedness) device related: not related procedure related: probable.Date of event: 1 oct 2025 date of implant: 21 aug 2024 date of revision: no information provided device location: c3-c4, c4-c5, c5-c6, c6-c7.Treatment/impact: oral/topical medication: yes.Depuy synthes products used: catalog number: cui8060s lot number: no information provided component type: no information provided description: eit cif cage, h 6mm, 8°, s.Catalog number: unk - screw lot number: no information provided component type: no information provided description: screw bone 16mm 3.5mm self drill variable angle.Catalog number: unk - rods lot number: no information provided component type: no information provided description: no information provided.Catalog number: cui8070s lot number: no information provided component type: no information provided description: eit cif cage, h 7mm, 8°, s.Catalog number: unk - screw lot number: no information provided component type: no information provided description: screw bone 16mm 3.5mm self drill variable angle (b)(6).Catalog number: unk - rods lot number: no information provided component type: no information provided description: no information provided.Catalog number: cui8060s lot number: no information provided component type: no information provided description: eit cif cage, h 6mm, 8°, s.Catalog number: unk - screw lot number: no information provided component type: no information provided description: screw bone 16mm 3.5mm self drill variable angle (b)(6).Catalog number: unk - rods lot number: no information provided component type: no information provided description: no information provided.Catalog number: cui8070s lot number: no information provided component type: no information provided description: eit cif cage, h 7mm, 8°, s.Catalog number: unk - screw lot number: no information provided component type: no information provided description: screw bone 16mm 3.5mm self drill variable angle (b)(6).Catalog number: unk - rods lot number: no information provided component type: no information provided description: no information provided.
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: added: b5, b14 (to capture dhr), d10 (concomitant).H3, h6: an analysis of the product could not be performed since a physical sample was not received for evaluation.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 review (dhr): part # cui8070s.Lot # 140699.Supplier: (b)(4).Mfg date: 23 jan 2024.No ncrs were generated during production.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.
Event or Problem Description
Additional information received: treatment/impact: there was reoperation/surgical intervention (posterior instrumentation) dated on (b)(6) 2025 for the additional device implanted not depuy devices for the treatment of c3-c4, c4-c5, c5-c6, c6-c7, c7-t1 and t1-t2 levels.Not depuy devices added: posterior rods and posterior screws.Magnetos putty bonegraft.

• Brand Name: CIF UI H 7MM 8DEG 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: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 23541473
• Report Number: 3013730328-2025-00058
• Device Sequence Number: 9458038
• Product Code: ODP
• UDI-Device Identifier: 04260557770573
• UDI-Public: (01)04260557770573(17)281231(10)140699
• 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: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study
• 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 Catalogue Number: CUI8070S
• Device Lot Number: 140699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2024
• 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: 4 LEVEL PLATE, 64MM; 4 LEVEL PLATE, 64MM; UNKNOWN RODS; UNKNOWN RODS; VARIABLE SELF DRILLING 3.5X16; VARIABLE SELF DRILLING 3.5X16
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Unknown
• Patient Weight: 53 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White