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 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

It was noted that the plate was bent near or around the locking mechanism.However, since the devices have not been returned for further analysis, the exact cause of the cover migration is unknown.

Event Description

The primary surgery occurred on (b)(6) 2023.Dr had a patient receive normal 3-month post-op x-rays during routine follow-up.After reviewing the x-ray dr noted that the bottom locking cap had dislodged.Dr is currently observing the patient and has no plans to revise.It was noted that the plate was bent near or around the locking mechanism.

• 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 75402
• Manufacturer Contact: todd wallenstein ; 2300 n haskell ave; dallas, TX 75402 ; 2146828536
• MDR Report Key: 18959652
• MDR Text Key: 338366021
• Report Number: 3012428435-2024-00033
• 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: 02/29/2024
• 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: 100-38VT12, QTY 4, SCREWS; 100-38VT14, QTY 3, SCREWS; 100-43VT12, QTY 2, SCREWS; 100-43VT14, QTY 1, SCREWS
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Prefer Not To Disclose
• Patient Weight: 68 KG