MAUDE Adverse Event Report: CERAPEDICS INC. I-FACTOR PUTTY; FILLER, BONE VOID, SYNTHETIC PEPTIDE

Model Number 700-050

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 05/01/2022

Event Type  Injury  

Manufacturer Narrative

Post-operative ct and x-ray images were provided by complainant.Images and relevant details were discussed with an external medical consultant and the following analysis was developed.With regard to causation/relatedness, judgement is that the patient's dysphagia is likely not related to the radiographic findings.Dysphagia is a well characterized complication associated with acdf surgery.The area of compression on the lateral swallow x-ray is at the c5 body, just cephalad the c5-6 disk space.There do not appear to be any significant hyperdensities (i-factor or bone) underlying that area on the 2 sagittal ct images that have been provided, nor does there appear to be any hyperdensity at that area on the swallow x-ray.The compression seen on the lateral swallow x-ray could represent soft-tissue scar, such as "balled up" longus colli muscle overlying the plate or another cause as may be associated with acdf surgery.The radiographic finding under investigation in this case is found at the c7 body, inferior to the plate and just cephalad to the c7-t1 disk space.That is not at the level of compression on the swallow x-ray.The hyperdensities have the appearance of the i-factor particulates/granules, not so much bone/heterotopic bone formation.The "trail" of i-factor to the posterior and then left of the esophagus and trachea is difficult to evaluate on the provided axial cuts, but neither image shows compression of the esophagus or trachea.We do not find connection of this material to the esophagus or vertebral bodies in the images provided to date.Also of note, c7 is not a level typically associated with dysphagia.For all of these reasons, it seems reasonable to conclude the radiographic finding at c7 is unrelated to the patient's dysphagia and posterior esophageal compression seen at c5.With regard to the radiographic finding being unresorbed graft material or ectopic bone, our finding is that this is unresorbed graft material.This finding is consistent with long standing observations in the worldwide clinical history of i-factor since 2008 as well as ectopic bone formation specific preclinical studies.These images collectively and individually don't suggest the presence of ectopic bone formation and/or densification and consolidation.There is no evidence of capsule, neocortex, inflammatory changes surrounding the tail etc.The material in the axial image at the second time point looks consistent with material not connected to any boney structure and which is comprised of distinct radiodense particles and clumps of particles.This is consistent with i-factor clinical experiences as well as animal models demonstrating i-factor purposefully in soft tissue does not elicit ectopic bone formation."superior laryngeal nerve injury and dysphagia" are listed as potential adverse events in the ifu.Additional information: most recent ct scan on (b)(6) 2023 - "unchanged linear hyperdensity material extending from the posterior aspect of the proximal esophagus at the level of c7-t1 and tracking along the left tracheoesophageal groove medial to the left carotid space.Findings again probably postsurgical in nature.".

Event Description

Patient presented with migration of the bone void filler from the graft site, resulting in patient pain and dysphagia.Patient contacted cerapedics after closure of c22-110 complaining of on-going neck pain near c7 on the left lower side stating that they have gotten 4 ct scans in less than 28 mos and several other tests.The ct results remain unchanged.

• Brand Name: I-FACTOR PUTTY
• Type of Device: FILLER, BONE VOID, SYNTHETIC PEPTIDE
• Manufacturer (Section D): CERAPEDICS INC.; 11025 dover street; suite #1600; westminster CO 80021
• Manufacturer Contact: emily aulby ; 11025 dover street; suite #1600; westminster, CO 80021
• MDR Report Key: 18886676
• MDR Text Key: 337450431
• Report Number: 3007155473-2024-23133
• Device Sequence Number: 1
• Product Code: NOX
• UDI-Device Identifier: 00850001680028
• UDI-Public: (01)00850001680028(17)240531(10)21C0969
• Combination Product (y/n): Y
• PMA/PMN Number: P140019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/11/2024

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 Expiration Date: 05/31/2024
• Device Model Number: 700-050
• Device Lot Number: 21C0969
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2021
• 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
• Treatment: UNKNOWN CERVICAL PLATE SYSTEM
• Patient Outcome(s): Other
• Patient Age: 66 YR
• Patient Sex: Female