MAUDE Adverse Event Report: CERAPEDICS I-FACTOR; PUTTY

Model Number	700-010
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Dyspnea (1816); Seroma (2069)
Date of Event	10/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The us instructions for use (ifu) for putty (40002-07-5) identify "soft tissue damage or fluid collections, including hematoma or seroma" also "wound complications including hematoma, site drainage, infection, dehiscence, and/or necrosis" as potential adverse events associated with any surgical procedure.No updates to the ifu are warranted at this time.Based on the investigation performed, a causal link between i-factor and the adverse event cannot be established.Observed rates of wound complications are within expected levels.
Event or Problem Description
On (b)(6) 2025, a surgeon reported a seroma after the patient returned to the emergency room with breathing difficulties three days post single-level acdf using the i-factor putty product.The quality team followed up with the surgeon for more details.The surgeon provided the surgery date, hospital name, product lot number, and confirmed no revision surgery was performed.Additional information included other products used during the procedure and a clinical narrative describing the event.

• Brand Name: I-FACTOR
• Common Device Name: PUTTY
• Manufacturer (Section D): CERAPEDICS; 11025 dover st.; #1600; broomfield CO 80021 5565
• Manufacturer (Section G): CERAPEDICS; 11025 dover st; #1600; broomfield CO 80021 5565
• Manufacturer Contact: lauren kunkel ; 11025 dover st.; #1600; broomfield, CO 80021-5565 ; 7208820690
• MDR Report Key: 23659322
• Report Number: 3007155473-2025-25310
• Device Sequence Number: 13275715
• Product Code: NOX
• UDI-Device Identifier: 00850001680004
• UDI-Public: (01)00850001680004(17)280229(10)25C2341
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P140019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2025

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
• Operator of Device: Health Professional
• Device Model Number: 700-010
• Device Lot Number: 25C2341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male