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

Catalog Number	100-3L55
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 original surgery occurred on (b)(6) 2024.Dr had a patient receive normal 1-month post-op x-rays during routine follow-up.After reviewing the x-ray dr noted that the bottom screws were backing out.Dr then performed a revision on (b)(6) 2024 to remove the plate.The hospital disposed of the plate.No x-rays were provided.No images of the plate, coverplate, or screws were provided.
Additional Manufacturer Narrative
Since the devices have not been returned for further analysis and no x-rays were provided, the exact cause of the cover 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 75204
• Manufacturer Contact: todd wallenstein ; 2300 n haskell ave; dallas, TX 75204 ; 2146828536
• MDR Report Key: 19264350
• Report Number: 3012428435-2024-00035
• Device Sequence Number: 6492861
• Product Code: KWQ
• UDI-Device Identifier: 00195860013021
• UDI-Public: 00195860013021
• 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: 2024
• 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: 100-3L55
• Device Lot Number: 0451
• 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: 04/12/2024
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2022
• 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: 100-38V14, QTY 2, SCREWS; 100-38V16, QTY 6, SCREWS
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 68 KG