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

Model Number 950-050

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/15/2023

Event Type  Injury  

Manufacturer Narrative

The dhr was reviewed for lot 21l0151 and indicated no abnormal processing.The lot in question met all specifications prior to its release.There have been no ncrs or capas associated with this lot.Ous flex fr ifu (p/n 40002-06-2) lists the following as a potential adverse effect: "extrusion or migration of the bone void filler, as is possible with any bone void filler, resulting in pain, neural impingement, physical impairment, irritation or wear of an articulating joint, or loss of function; any of which may require revision surgery".As such, no updates are required for the ifu.Based on the information gathered, there is no causal link between the flex fr product and the migration.As listed in the ifu (p/n 40002-06-2), migration is listed as a potential adverse effect.

Event Description

Revision of a previous c3- t2 posterior cervical fusion, surgical date was (b)(6) 2021.I-factor flex had been used in that construct as per surgical technique.Surgical debris present.Revision was for unknown reason.

• 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: 18955757
• MDR Text Key: 338307743
• Report Number: 3007155473-2024-23126
• Device Sequence Number: 1
• Product Code: MBS
• UDI-Device Identifier: 008500073
• UDI-Public: (01)008500073(17)240331(10)21L0151
• 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 Expiration Date: 03/31/2024
• Device Model Number: 950-050
• Device Lot Number: 21L0151
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2021
• 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