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

Model Number	100-4L66
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An emerge cover dislodged from the plate after the surgeon attempted to turn the cover past a screw that was beyond the acceptable angle.The screw head was too proud and led to the cover dislodging.The surgeon then simply placed the dislodged cover back into the plate and closed the patient.Since the cover was dislodged, the strength of the cover has been compromised and may increase the probability of occurrence of screw backout.The surgeon should have replaced the plate with a new plate.
Additional Manufacturer Narrative
The surgeon admitted that he knowingly placed the emerge screws at an angulation that was beyond the limits of the system, which contributed to the cover dislodging.The surgeon also admitted that he knowingly did not replace the emerge plate after the cover had been damaged.

• Brand Name: EMERGE ANTERIOR CERIVCAL PLATE SYSTEM
• 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: 17396826
• Report Number: 3012428435-2023-00025
• Device Sequence Number: 7722006
• Product Code: KWQ
• UDI-Device Identifier: 00195860013137
• UDI-Public: 00195860013137
• 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): 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100-4L66
• Device Catalogue Number: 100-4L66
• 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: 07/04/2023
• Initial Report FDA Received Date: 07/26/2023
• 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 4 - SCREW DIA 3.75 X 14MM; 100-38VT16, QTY 6 - SCREW DIA 3.75 X 16 MM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic