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

Catalog Number	100-2L38
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The surgeon was pre-planning a revision in order to extend an older construct by 2 levels due to adjacent segment disease.The primary surgery occurred on (b)(6) 2022.There was no mention of screw backout from the surgeon.A review of the x-ray it was observed that the bottom screw was backing out and the cover had displaced.Surgeon did not revise because of the backout, but because of the adjacent segment disease.
Additional Manufacturer Narrative
The device was returned, but with missing components.The exact cause of the issue 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 75204
• Manufacturer Contact: todd wallenstein ; 2300 n haskell ave; dallas, TX 75204 ; 2146828536
• MDR Report Key: 19264366
• Report Number: 3012428435-2024-00036
• Device Sequence Number: 15076401
• Product Code: KWQ
• UDI-Device Identifier: 00195860012888
• UDI-Public: 00195860012888
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212405
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 05/07/2024

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: 100-2L38
• Device Lot Number: 0100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/29/2021
• 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, SCREWS; 100-38V18, QTY 4, SCREWS
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 68 KG