MAUDE Adverse Event Report: COFLEX COFLEX; PROSTHESIS, SPINOUS PROCESS SPACER/PLATE

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

Patient Problems Fever (1858); Pain (1994); Post Operative Wound Infection (2446)

Event Type  Injury  

Event Description

The patient reported that they had spinal surgery in (b)(6) 2016 and used a coflex device.For the first 5 days they were fine, however, on day 6 they developed a fever, were not feeling well, and their pain started returning.The patient also reported that at their post-op appointment around memorial day, their pain was 100 times worse than prior to the surgery and that there was pus coming out of the surgical site and that it was infected.The patient stated that 41-66 cc fluid was drained from the site and they were given a prescription for physical therapy.On (b)(6)13, the patient has emergency surgery and the site was cleaned out and they were given antibiotics.601497394.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: COFLEX
• Type of Device: PROSTHESIS, SPINOUS PROCESS SPACER/PLATE
• Manufacturer (Section D): COFLEX
• MDR Report Key: 17525415
• MDR Text Key: 321159871
• Report Number: MW5132356
• Device Sequence Number: 1
• Product Code: NQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1