MAUDE Adverse Event Report: CERAPEDICS INC I-FACTOR PUTTY; FILLER, BONE VOID, SYNTHETIC PEPTIDE

Model Number UNKNOWN

Device Problem Migration (4003)

Patient Problem Seroma (2069)

Event Type  Injury  

Event Description

Surgeon stated that around the 2019 time frame he used i-factor on 2 patients in cervical procedures.He stated that in both patients a seroma formed and in one of the patients a calcified shell or "cap" had formed in the tissue away from the bone.The actual date of these cases was not given.On may 4, 2023 via email surgeon stated that one patient underwent a revision surgery for the seroma and to washout the i-factor granules which were being extruded through the incision.He also stated that he does not have any additional product information.

Manufacturer Narrative

As no lot number was provided a dhr review could not be completed.Additionally, as no lot number was provided a review of capas and ncrs could not be completed.Cerapedics risk analysis document (b)(4), revision 23 (putty) was reviewed.The failure mode identified in this complaint is already identified under line item 40, - "wound complications including hematoma, site drainage, and infection." therefore, no updates to the risk assessment are required.There have been 0 (zero) previous complaints related to this potential failure mode.Based on the total number of units distributed (n=265,783), the observed rate is (b)(4).The mitigated risk probability for this potential failure mode is estimated to be 2 or an estimated occurrence rate of (b)(4).Therefore, the benefit-risk analysis remains unchanged.Us putty ifu (p/n 40002-07-4) lists the following as a potential adverse effect: "wound complications including hematoma, site drainage, infection dehiscence and/or necrosis" and "soft tissue damage of fluid collections, including hematoma or seroma".Additionally, the ifu states: "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."as such, no updates are required for the ifu.

• Brand Name: I-FACTOR PUTTY
• Type of Device: FILLER, BONE VOID, SYNTHETIC PEPTIDE
• Manufacturer (Section D): CERAPEDICS INC; 11025 dover street; suite #1600; westminster CO 80021
• Manufacturer Contact: emily aulby ; 11025 dover street; suite #1600; westminster, CO 80021
• MDR Report Key: 18886326
• MDR Text Key: 337445554
• Report Number: 3007155473-2024-23127
• Device Sequence Number: 1
• Product Code: NOX
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P140019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other