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

Catalog Number	100-3L54
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The primary surgery occurred on (b)(6)2023.On (b)(6)2023, a patient visited on a routine follow-up appointment.After reviewing the x-ray on 08/23/2024, the lateral images above show that between the immediate post-op and follow up x-ray that the 2 screws placed in c7 had backed out and the cover plate is floating next to the plate.
Additional Manufacturer Narrative
A highly medialized screw could put additional loads on the cover plate that could contribute to the cover separating from the plate.The position of the screws was simulated using the 3d cad model.The screws were placed in a similar manner to the anterior x-ray, and the plate and cover were made to be transparent to simulate the x-ray.The 3d cad looks to be a reasonable facimile of the position of the screws.When rotating the 3d cad model, it shows that when the screw is medialized as much as is shown in the x-ray, the screw head interferes with the cover.If the screw was placed in the same medial orientation as shown in the cad model during the primary procedure, then it would have been very difficult to lock the cover.If the cover was overpowered, then it could pull the cover up and out of the plate.The surgeon may or may not be aware that the cover was compromised in this situation.The angulation of the right screw appears to be beyond the angulation limits.In addition, it is notable that all of the cages are contacting the plate.If the cages move they could put additional pressure on the plate and screws.This event may have occurred due to over medializing the lower screw leading to excessive force on the cover.However, since the devices have not been returned for further analysis, the exact cause of the screw backout is unknown.

• Brand Name: EMERGE ANTERIOR CERVICAL PLATE
• Common Device Name: ANTERIOR CERVICAL PLATE
• Manufacturer (Section D): EVOLUTION SPINE LLC; 2300 n haskell ave; dallas TX 75402
• Manufacturer (Section G): EVOLUTION SPINE LLC; 2300 n haskell ave; dallas TX 75402
• Manufacturer Contact: todd wallenstein ; 2300 n haskell ave; dallas, TX 75402 ; 2146828536
• MDR Report Key: 17749211
• Report Number: 3012428435-2023-00029
• Device Sequence Number: 17508162
• Product Code: KWQ
• UDI-Device Identifier: 00195860013052
• UDI-Public: 00195860013052
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K212405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 09/14/2023

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: 100-3L54
• Device Lot Number: 0117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• 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 2, SCREW DIA 3.75 X 16 MM; 100-38V18, QTY 4, SCREW DIA 3.75 X 18 MM; 100-43V18, QTY 4, SCREW DIA 4.25 X 18 MM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic