MAUDE Adverse Event Report: CERAPEDICS, INC. IFACTOR PEPTIDE ENHANCED BONE GRAFT; FILLER, BONE VOID, SYNTHETIC PEPTIDE

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Neck Pain (2433)

Event Date 09/08/2021

Event Type  Injury  

Event Description

Adverse event no follow up; on (b)(6) 2021 a multi level acdf (c3-c7) procedure was performed on me by (b)(6) md ((b)(6)), using cerapedics product i-factor.In (b)(6) 2021 on a ct scan performed due to unrelenting neck pain on the left side.It showed a linear calcification/ossification coursing anterior and left laterally from c6 /c7 disc level extending posterior to the esophagus, extending anteriorly interposed between the thyroid and left carotid jugular vasculature extending to the sternomastoid muscle on the left side.Repeated ct (b)(6) 2022 this linear material has now consolidated into bone in the soft tissue as defined above.It appears that the product ifactor migrated from the contained surgical area into my soft tissue as described above.There has been no resolution to the cause or ultimate outcome of this product being in the soft tissue of my neck.I continue to have neck pain on thee left side.I have questioned dr (b)(6) multiple times about this and he claimed originally that i should not be concerned in that it was an incidental finding.He has claimed to have reached out to colleagues, other physicians and to the company cerapedics.He has maintained that he has no idea why this has happened and seems to have no intention of finding out.I've had to reach out to him on this topic, he has never reached out to me about it - only in response.On (b)(6) 2022 he said that the consolidated bone was an adverse event.On (b)(6) 2022 he claimed to have reported this to cerapedics and supposedly they have filed a safety report and an icsr to the fda.It has been over 6 weeks with continual no follow up.I have reached out to (b)(6) on (b)(6) 2022 the head of cerapedics.He has neither responded or has shown any follow-up either.A side of my own mental and physical concerns in relationship to this product coursing through my soft tissue.Since this finding appears to go unfollowed without resolution, and it was not anticipated or acknowledged in my consent prior to the surgery as a possibility.I question if dr.(b)(6) has updated his consent, and if cerapedics has updated their product brochure.Since they both have been aware of this finding since (b)(6) 2021, with no known cause, resolution or outcome - that they are practicing negligence with every single patient that has received this product since (b)(6) 2021.Actual ct scans can be provided there is one (b)(6) 2021 prior to surgery, (b)(6) 2021 post surgery and (b)(6) 2022 also post surgery.Consolidation of ifactor product has clearly hardened to bone in soft tissue of the esophagus, thyroid, left carotid artery, and the sternomastoid muscle.All documented in the ct scans.Reason for use: surgically implanted as a bone graft.Fda safety report id# (b)(4).

• Brand Name: IFACTOR PEPTIDE ENHANCED BONE GRAFT
• Type of Device: FILLER, BONE VOID, SYNTHETIC PEPTIDE
• Manufacturer (Section D): CERAPEDICS, INC.
• MDR Report Key: 14488138
• MDR Text Key: 292580263
• Report Number: MW5109840
• Device Sequence Number: 1
• Product Code: NOX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: ADVIL ; AMBIEN; BUT/ACETAMINOPHEN; OMEPRAZOLE; ONDANSETRON
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White