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

Catalog Number	100-4L70
Medical Device Problem Code	Misassembly by Users (3133)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The screw appears to be at a high angulation at the top and bottom of the constructs, which we have seen in the past could contribute to cover backout.Between the 3 month and 12-month x-rays it does appear that the top and bottom screws have also translated, potentially due to settling of the interbody cages, that can also lead to additional stress on the covers.Since the devices have not been returned for further analysis, the exact cause of the cover backout is unknown.
Event or Problem Description
The primary surgery occurred on (b)(6) 2022.Dr had a patient receive normal post-op x-rays during routine follow-up (the follow-up occurred 15 months after primary surgery).After reviewing the x-ray dr noted that the top locking cap had dislodged.

• 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: 18959686
• Report Number: 3012428435-2024-00034
• Device Sequence Number: 14597376
• Product Code: KWQ
• UDI-Device Identifier: 00195860013144
• UDI-Public: 00195860013144
• 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: 2022
• 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): 03/22/2024

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: 100-4L70
• Device Lot Number: 0463
• 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: 03/06/2024
• Initial Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 1, SCREWS; 100-38VT16, QTY 9, SCREWS
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 68 KG