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

Catalog Number	100-1L18
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 (b)(6) 2023, the lateral images above show that between the immediate post-op and follow up x-ray that the 2 screws placed in c5 had backed out and the cover plate is floating above the plate.
Additional Manufacturer Narrative
An approximation was made to compare the 3d model to the x-ray image.From this analysis it looks like the bottom screws were overangulated by about 5° past the maximum allowable screw angle.Also, it is possible to see the edge of the screw sticking slightly above the plate profile (circled below), which is another indicator that the screw was inserted beyond the maximum allowable angle.When screws are inserted over angled they put more pressure on the cover plate.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 angulating the lower screws 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: 17749797
• Report Number: 3012428435-2023-00030
• Device Sequence Number: 14772755
• Product Code: KWQ
• UDI-Device Identifier: 00195860012741
• UDI-Public: 00195860012741
• 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: 100-1L18
• Device Lot Number: 0387
• 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: 04/18/2022
• 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 4, DIA 3.75X16MM SCREW
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic