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

Model Number 900-050

Device Problem Migration (4003)

Patient Problem Pain (1994)

Event Date 06/13/2023

Event Type  Injury  

Event Description

Patient was initially operated upon in (b)(6) 2021.Surgery was a single level lateral interbody procedure in which i-factor putty was inserted into stryker lateral access and cascadia cage k2m.Two weeks post-surgery, the patient experienced leg and thigh pain which was consistent with si joint issues.No relief with nerve blocks and continued issues / pain on leg raise.Initially reported to cerapedics on 8 jul 2022.On may 3, 2023 quality was made aware that the surgeon would move forward with a revision surgery for his patient.On (b)(6), 2023, revision surgery occurred.Surgery was exploratory in nature to further evaluate observed migration.Histology was requested to evaluate tissue.

Manufacturer Narrative

As no lot number was provided a dhr review could not be completed.Additioanlly, as no lot number was provided a review of capas and ncrs could not be completed.Following the revision surgery on (b)(6) 2023, tissue specimens were sent to histology to be further examined.In the specimen, extruded commercial bone graft was observed.Microscopically, specimens show lacunae filled with synthetic bone-like material mimicking calcium phosphate deposits.These lacunae are bounded by mature skeletal muscle bundles.Scar tissue and fat necrosis are noted.No acute inflammation was seen.No atypia or malignancy was seen.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 2) - "inadequate retention in graft site, migration." therefore, no updates to the risk assessment are required.There have been 7 (seven) previous complaints related to this 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 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.

• 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: 18886096
• MDR Text Key: 337442291
• Report Number: 3007155473-2024-22118
• Device Sequence Number: 1
• Product Code: NOX
• Combination Product (y/n): Y
• Reporter Country Code: UK
• 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
• 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: 900-050
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 07/08/2022
• Supplement Dates FDA Received: 03/25/2024
• 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
• Treatment: STRYKER LATERAL ACCESS AND CASCADIA CAGE K2M.
• Patient Outcome(s): Other
• Patient Sex: Female