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

Model Number 900-010

Device Problem Migration (4003)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/13/2023

Event Type  Injury  

Manufacturer Narrative

The design history record was reviewed for lot 21c1004 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 (b)(4), revision 23 (putty) was reviewed.The failure mode identified in this complaint is already identified under line item 38 (potential effect 2) - "inadequate retention in graft site, migration." therefore, no updates to the risk assessment are required.There have been 9 (nine) 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 1 or an estimated occurrence rate of (b)(4) therefore, the benefit-risk analysis remains unchanged.Ous putty ifu (p/n 40002-01-10) lists the following as a potential adverse effect: "extrusion or migration of the bone void filler, as is possible with any bone void filler, resulting in pain, neural impingement, physical impairment, irritation or wear of an articulating joint, or loss of function; any of which my require revision surgery." as such, no updates are required for the ifu.

Event Description

I-factor migrated out of cervical cage and spread over the dura mater and left c5 and c6 foramen.Revision surgery to remove i-factor.

• 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: 18886929
• MDR Text Key: 337453737
• Report Number: 3007155473-2024-23139
• Device Sequence Number: 1
• Product Code: NOX
• UDI-Device Identifier: 00850001680158
• UDI-Public: (01)00850001680158(17)240630(10)21C1004
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: P140019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/11/2024
• 2 Devices were Involved in the Event: 1 2

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: 900-010
• Device Lot Number: 21C1004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 07/18/2023
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/13/2022
• 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
• Treatment: UNKNOWN CERVICAL CAGE
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Male