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

Model Number	700-050
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Unknown white milky liquid inside the package.

• Brand Name: I-FACTOR¿ PEPTIDE ENHANCED BONE GRAFT
• Common Device Name: FILLER, BONE VOID, SYNTHETIC PEPTIDE
• Manufacturer (Section D): CERAPEDICS INC.; 11025 dover street; suite 1600; westminster CO 80021
• MDR Report Key: 21078897
• Report Number: 21078897
• Device Sequence Number: 6765548
• Product Code: NOX
• UDI-Device Identifier: 00850001680028
• UDI-Public: (01)00850001680028(17)261231(10)24C1947
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/19/2024
• Report Date (Section F): 12/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 700-050
• Device Catalogue Number: 700-050
• Device Lot Number: 24C1947
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/06/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/06/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 12/19/2024