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

Catalog Number	100-4L74
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The primary surgery occurred on (b)(6) 023.Evolution was conducting a cadaver lab with the doctor (on an unrelated project) on (b)(6) 2023 (date of awareness) and he mentioned that he had a cover come off of an emerge plate.The doctor did not provide any images or additional details other than that the lowest plate cover was shown as displaced on a routine follow-up x-ray.The doctor said that the patient is still being monitored.No revision has been scheduled.

• 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: 18470292
• Report Number: 3012428435-2023-00032
• Device Sequence Number: 6924522
• Product Code: KWQ
• UDI-Device Identifier: 00195860013151
• UDI-Public: 00195860013151
• 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: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 01/08/2023

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: 100-4L74
• Device Lot Number: 0464
• 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: 12/08/2023
• Initial Report FDA Received Date: 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• 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: 100-38VT14, QTY 10 - CERVICAL SCREW DIA 3.75 X 14.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 50 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic