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

Catalog Number 100-4L70

Device Problem Misassembly by Users (3133)

Patient Problem Failure of Implant (1924)

Event Date 03/06/2024

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 338366214
• Report Number: 3012428435-2024-00034
• Device Sequence Number: 1
• Product Code: KWQ
• UDI-Device Identifier: 00195860013144
• UDI-Public: 00195860013144
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 100-4L70
• Device Lot Number: 0463
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 100-38VT14, QTY 1, SCREWS; 100-38VT16, QTY 9, SCREWS
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 68 KG