MAUDE Adverse Event Report: CERAPEDICS I-FACTOR FLEX FR; FILLER, BONE VOID, NON-OSTEOINDUCTION

Model Number 950-025

Device Problem Migration (4003)

Patient Problem Malunion of Bone (4529)

Event Date 10/25/2023

Event Type  Injury  

Manufacturer Narrative

As no lot number was provided a dhr review could not be completed.Ous flex fr ifu (p/n: 40002-06-2) lists the following as a potential adverse effect: "nonunion, malunion, or delayed union".As such, no updates are required for the ifu.Based on the information available, a causal link between the flex fr product and the nonunion cannot be established.

Event Description

This patient had their initial posterior lumbar interbody fusion surgery in 2021 by another surgeon where a 25mm i-factor was used in the posterolateral gutters.The patient underwent revision surgery on (b)(6) 2023 by a difference surgeon and the surgeon noted that the i-factor was still visible in the patient and had not appeared to have "broken down or integrated" post operatively since 2021.There appeared to be large clumps of i-factor (or possibly hydroxyapatite) attached to the patient's tissue.The patient's initial surgery (2021) failed to fuse hence why a revision surgery was necessary.

• Brand Name: I-FACTOR FLEX FR
• Type of Device: FILLER, BONE VOID, NON-OSTEOINDUCTION
• Manufacturer (Section D): CERAPEDICS; 11025 dover street; suite 1600; westminster CO 80021
• Manufacturer Contact: emily aulby ; 11025 dover street; suite 1600; westminster, CO 80021
• MDR Report Key: 18956017
• MDR Text Key: 338305233
• Report Number: 3007155473-2024-23151
• Device Sequence Number: 1
• Product Code: MBS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P140019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 950-025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: No
• 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): Other