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

Model Number 700-050

Device Problem Migration (4003)

Patient Problem Swelling/ Edema (4577)

Event Date 03/21/2023

Event Type  Injury  

Manufacturer Narrative

The dhr was reviewed for lot 22c1297 and indicated no abnormal processing.The lot in question met all specifications prior to its release.There have been no ncrs or capas associated with this lot.Cerapedics risk analysis document ra-001, revision 23 (putty) was reviewed.The failure mode identified in this complaint is already identified under line item 38 (potential effect 3) - "inadequate retention in graft site, migration." therefore, no updates to the risk assessment are required.There has been 1 (one) previous complaint related to this potential failure mode.Based on the total number of units distributed (n=(b)(4)), the observed rate is (b)(4) %.The mitigated risk probability for this potential failure mode is estimated to be 1 or an estimated occurrence rate of 0.01%.Therefore, the benefit-risk analysis remains unchanged.Us putty ifu (p/n 40002-07-4) lists the following: "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.

Event Description

Surgeon initially saw the patient on (b)(6) 2023 for a scheduled 2-level acdf at c3/c5.No adverse events occurred during surgery and patient presented with no complications immediately post-op.The patient returned to surgeon's office on (b)(6) 2023, 5 days post-op with significant anterior and left tracheal swelling with tenderness to palpation.The patient's difficulty swallowing raised concern as the patient was unable to eat or drink anything including water.The patient was sent directly back to delray medical center emergency room for admission.Cervical a/p and lateral x-rays show significant pre-vertebral swelling with anterior c2-c7 displacement (27mm) of the trachea without displacement from midline.

• 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: 18886502
• MDR Text Key: 337448620
• Report Number: 3007155473-2024-23131
• Device Sequence Number: 1
• Product Code: NOX
• UDI-Device Identifier: 00850001680028
• UDI-Public: (01)00850001680028(17)250531(10)22C1297
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 700-050
• Device Lot Number: 22C1297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2022
• 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
• Patient Age: 58 YR
• Patient Sex: Male