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	Dysphagia/ Odynophagia (1815); Dyspnea (1816); Hematoma (1884); Vomiting (2144); Speech Disorder (4415)
Date of Event	09/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Us putty ifu (40002-07-5) lists "wound complications including hematoma." and "dysphagia" as a potential adverse effects with surgery specifically anterior cervical discectomy and fusion; therefore no updates to the ifu are required.Based on the available data, including dhr review and risk analysis, the reported event aligns with a known and mitigated failure mode.A causal link between i-factor and the adverse event cannot be established.
Event or Problem Description
On (b)(6) 2025, a patient underwent a c4-c6 for left c5 and c6 cervical radiculopathy and left c4-5 and c5-6 foraminal stenosis, associated with scapular winging, and periscapular pain unresponsive to conservative treatment.Intraoperatively ".A full diskectomy was performed at c4-5.End plates were now prepared and appropriately sized interbody cage implant was tamped into place packed with local autograft bone from the osteophyte resection as well as ifactor bone graft.Titanium anterior fixation was applied for further stabilization.Secondary locking mechanism was engaged.Full diskectomy was performed at c5-6.End plates were now prepared and appropriately sized interbody cage implant was tamped into place packed with local autograft bone from the osteophyte resection as well as ifactor bone graft.Titanium anterior fixation was applied for further stabilization.Secondary locking mechanism was engaged." the patient was discharged home on (b)(6) 2025.On (b)(6) 2025, he contacted the surgeon's office reporting dysphagia, partial regurgitation of liquids, odynophagia, and hoarseness.Mucinex was recommended.On (b)(6) 2025, the patient reported worsening symptoms including neck swelling, increased hoarseness, and difficulty breathing.He was instructed to go to the nearest er, where he was intubated for airway protection and transferred to hospital for special surgery (hss) for urgent surgical intervention.Intraoperatively, a small hematoma was evacuated.The fluid appeared purulent but was not frank pus.A methylene blue og tube challenge test and operating room cultures were performed and came up negative, and the patient was started on vancomycin and zosyn therapy.During hospitalization, the patient was managed by infectious disease, nutrition, physical therapy, pain management, and speech therapy.An esophagram on (b)(6) 2025 showed no leak.Oral nutritional supplementation was provided due to inadequate intake since surgery.Antibiotics were discontinued on (b)(6) 2025.The patient remained afebrile with no signs of infection.The patient was discharged home on (b)(6) 2025 and is scheduled for follow-up cervical spine x-rays and an office visit with the spine surgeon on (b)(6) 2025.Other products/materials used: 1.Waveform c interbody cage 18x15x7mm 7-degree 3d, ti alloy; manfacturer: seaspine - 2 units implanted.2.Screw bone spine 18mm 3.5mm shoreline asc ns slf tap va; manufacturer: seaspine - 3 units implanted.3.Screw 4.0mm variable self tapping 18mm; manufacturer: seaspine - 1 unit implanted 4.Plate 2-hole anterior 7mm; manufacturer: seaspine - 2 units impanted.5.Screw 3.5mm variable self tapping 16mm; manufacturer: seaspine- 1 unit implanted 6.Locking cover 7mm; manufacturer: seaspine; used 2 units.Local autograft bone was mixed with i-factor.

• 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: 23316315
• Report Number: 3007155473-2025-25298
• Device Sequence Number: 20043263
• Product Code: NOX
• UDI-Device Identifier: 00850001680004
• UDI-Public: (01)00850001680004(17)280131(10)25C2321
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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: Risk Manager
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 10/14/2025

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: 25C2321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2025
• 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: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White