MAUDE Adverse Event Report: EVOLUTION SPINE LLC EMERGE ANTERIOR CERVICAL PLATE

Catalog Number	100-2L42
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The surgery occurred on (b)(6) 2025.The doctor had a patient receive normal 1-month post-op x-ray as part of routine follow-up.After reviewing the x-ray, the doctor noted the bottom screws were backing out and the cover was displaced.The pictures below show an x-ray intraoperatively after implantation during the initial surgery (left) and an x-ray at routine follow-up (right).A revision surgery was performed on (b)(6) 2026.The plate and screws were explanted and returned for review.
Additional Manufacturer Narrative
No reports of patient noncompliance or intervening events were provided.Review of intraoperative lateral x-ray indicates the c6/7 interbody device was positioned anterior to the anterior cortex of the c6 vertebral body, and the plate was not flush with the c7 vertebral body.The c7 screw trajectory measured approximately 25 degrees caudally.Follow-up lateral x-ray demonstrates posterior subsidence of the c6/7 interbody device into the c6 vertebral body and anterior subsidence into the c7 vertebral body.The c7 screw trajectory on follow-up imaging appears approximately neutral within the vertebral body.The returned plate, cover and screws were evaluated.No evidence of fracture, deformation, or material/manufacturing defect was identified.The c7 locking cover was observed to be disengaged.Based on x-ray review and device evaluation, interbody subsidence is considered the likely contributing factor to screw translation.The change in screw orientation would be expected to increase loading at the locking interface, which is consistent with the observed disengagement of the c7 locking cover.A manufacturing or material defect was not identified.The device history record (dhr) for the subject lot was reviewed.All manufacturing and acceptance activities were completed as required, and no nonconformances or deviations related to the reported event were identified.

• Brand Name: EMERGE ANTERIOR CERVICAL PLATE
• Common Device Name: ANTERIOR CERVICAL PLATE
• Manufacturer (Section D): EVOLUTION SPINE LLC; 2300 n. haskell ave.; dallas 75402
• Manufacturer (Section G): EVOLUTION SPINE LLC; 2300 n. haskell ave.; dallas TX 75402
• Manufacturer Contact: james mirda ; 2300 n. haskell ave.; dallas, TX 75402 ; 2142818871
• MDR Report Key: 24422336
• Report Number: 3012428435-2026-00059
• Device Sequence Number: 14965469
• Product Code: KWQ
• UDI-Device Identifier: 00195860012901
• UDI-Public: 00195860012901
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K212405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 02/23/2026

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: 100-2L42
• Device Lot Number: 0439
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 02/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2022
• 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: 100-38V16, QTY. 6 SCREWS.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 68 KG