MAUDE Adverse Event Report: SURGALIGN SPINE TECHNOLOGIES COFLEX INTERLAMINAR TECHNOLOGY; SPINOUS PROCESS PLATE

Model Number UQI00010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/06/2023

Event Type  Injury  

Event Description

During a follow up clinical study information was reported that patient underwent a procedure to remove a coflex device.No allegation of product malfunction reported.

Manufacturer Narrative

Received additional information related to patient history.Section b7 has been updated, patient underwent implant coflex procedure in 2021 no exact date provided.

• Brand Name: COFLEX INTERLAMINAR TECHNOLOGY
• Type of Device: SPINOUS PROCESS PLATE
• Manufacturer (Section D): SURGALIGN SPINE TECHNOLOGIES; 520 lake cook road; suite 315; deerfield IL 60015
• Manufacturer (Section G): SURGALIGN SPINE TECHNOLOGIES; 520 lake cook road; suite 315; deerfield IL 60015
• Manufacturer Contact: richard younger ; 520 lake cook road; suite 315; deerfield, IL 60015
• MDR Report Key: 16820635
• MDR Text Key: 314072583
• Report Number: 3005725110-2023-00004
• Device Sequence Number: 1
• Product Code: PEK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2023

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
• Device Operator: Health Professional
• Device Model Number: UQI00010
• Device Lot Number: 2015AA1533
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 04/06/2023; 06/20/2023
• Supplement Dates FDA Received: 05/17/2023; 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female