MAUDE Adverse Event Report: CERAPEDICS I-FACTOR; PUTTY

Model Number	700-025
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Neuropathy (1983); Neuralgia (4413)
Date of Event	08/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The us putty ifu pn: 40002-07-5 lists the following potential adverse events that may occur specifically with the use of i-factor peptide enhanced bone graft: "extrusion or migration of the i-factor peptide enhanced bone graft, as is possible with any bone graft, resulting in pain, neural impingement, physical impairment, or loss of function; any of which may require revision surgery." based on the available data, including dhr review, clinical documentation, and risk analysis, the reported event aligns with a known and mitigated failure mode.While ifactor cannot be conclusively identified as the root cause, its contribution cannot be ruled out.The complaint rate remains well below the estimated occurrence rate, and no updates to the risk file are required at this time.
Event or Problem Description
The patient underwent a multi-level cervical spine fusion procedure using i-factor peptide enhanced bone graft.Postoperatively, the patient developed acute c5 and c6 radiculopathies, presenting with pain and signs consistent with neural impingement.Imaging provided by the surgeon indicated possible migration of graft material from the intended site, which may have contributed to nerve root compression.The operative report noted mechanical neck pain and acute radiculopathy.While the exact root cause of the adverse event cannot be conclusively attributed to the device, graft migration is a known risk associated with bone grafting procedures and is listed in the device's instructions for use (ifu).Revision surgery was performed due to the severity of symptoms, and the patient has recovered and is improving.
Event or Problem Description
The patient underwent a multi-level cervical spine fusion procedure using i-factor peptide enhanced bone graft.Postoperatively, the patient developed acute c5 and c6 radiculopathies, presenting with pain and signs consistent with neural impingement.Imaging provided by the surgeon indicated possible migration of graft material from the intended site, which may have contributed to nerve root compression.The operative report noted mechanical neck pain and acute radiculopathy.While the exact root cause of the adverse event cannot be conclusively attributed to the device, graft migration is a known risk associated with bone grafting procedures and is listed in the device's instructions for use (ifu).Revision surgery was performed due to the severity of symptoms, and the patient has recovered and is improving.
Additional Manufacturer Narrative
Correction: initial reporter information additional information: device history record review for lot 24c2207 found no manufacturing deviations.The lot met all release specifications.The device was not returned for evaluation, as it was discarded following revision surgery. a clinical review of available records indicated that graft migration occurred, which is a known risk associated with bone graft materials, however, the records provided were insufficient to conclusively determine whether all technical aspects of containment recommended in the ifu were adhered to.The device labeling (ifu pn 40002-07-5) identifies migration as a potential adverse event.The device was used in a two-level acdf procedure, which is outside the cleared indication for single-level use and may represent a contributing factor.Based on the available information, a definitive root cause could not be identified; the role of the device in the event remains unclear.The reported event is consistent with a known risk of graft migration described in the device labeling.

• Brand Name: I-FACTOR
• Common Device Name: PUTTY
• Manufacturer (Section D): CERAPEDICS; 11025 dover st; #1600; broomfield CO 80021
• Manufacturer (Section G): CERAPEDICS; 11025 dover st.; #1600; broomfield CO 80021
• Manufacturer Contact: adam rockwell ; 11025 dover st; #1600; broomfield, CO 80021
• MDR Report Key: 23183597
• Report Number: 3007155473-2025-25294
• Device Sequence Number: 9992321
• Product Code: NOX
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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: 700-025
• Device Lot Number: 24C2207
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 06/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2024
• 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: 63 YR
• Patient Sex: Female