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

Model Number 700-050

Device Problem Migration (4003)

Patient Problem Seroma (2069)

Event Type  Injury  

Event Description

Surgeon stated that he has had a couple compressive seromas on consecutive posterior lateral patients.When opening the wound ifactors was found.This concerned him.Required return to or.Report for 2 of 2 surgeries reported.

Manufacturer Narrative

Complaint investigation ongoing.Will review manufacturing records, similar complaints, ifu and risk anaylsis.

Manufacturer Narrative

Device history record the design history record was reviewed for lot 23c1551 and indicated no abnormal processing.The lot in question met all specifications prior to its release.Aside from the associated complaint from dr.Sebastian (c24-160), no other complaints have been received for lot 23c1551.Capas and ncrs associated with lot there have been no ncrs or capas associated with this lot.Risk analysis and previous complaints cerapedics risk analysis document ra-001, 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 3 (three) previous complaints related to this potential failure mode.Based on the total number of units distributed (n=286,101), the observed rate is 0.001%.The mitigated risk probability for this potential failure mode is estimated to be 2 or an estimated occurrence rate of 0.25%.Therefore, the benefit-risk analysis remains unchanged.Us putty ifu ((b)(4)) lists the following under potential adverse events: "wound complications including hematoma, site drainage, infection, dehiscence and/pr necrosis".As such, no updates are required for the ifu.Conclusion based on the information available, no causal link could be established between i-factor putty and the reported complaint.Other potential contributing factors to consider are the surgical technique used, the patient's physiology/condition, and/or concomitant devices used for the surgery.The ifu clearly lists wound complications as a potential adverse event; therefore, no additional action is required.

• 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: 18886823
• MDR Text Key: 337452329
• Report Number: 3007155473-2024-24163
• Device Sequence Number: 1
• Product Code: NOX
• Combination Product (y/n): Y
• 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,Followup
• 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 Model Number: 700-050
• Device Lot Number: 23C1551
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• 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