MAUDE Adverse Event Report: CERAPEDICS, INC. I-FACTOR PEPTIDE ENHANCED BONE GRAFT

Model Number	700-050
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided suggests the surgery was a lumbar interbody fusion performed without a cage and was mixed with allograft, all of which are not within the approved indicated labeling.If no interbody ring or cage was used, containment of the bone graft would likely be challenging, increasing the risk of migration.This is the 42nd report of migration (internal and external) for all i-factor product types.There have been approximately (b)(4) surgeries performed using i-factor products at the time of the event.Based on the current number of migration complaints the frequency of i-factor migration is ~(b)(4)%.Migration is a known potential risk of any bone graft material, including autograft.The current ifu package insert lists migration of the graft material as a potential adverse event, and there is also a statement of risk about the potential need for revision surgery.The dhr for lot 18c0493 indicates no discrepancies or deviations that may have contributed to the incident.There are no other similar complaints/incidents reported for this lot of product.Requested additional information from dr.(b)(6) via email on (b)(4) 2018.No response to email.No further information available.
Event or Problem Description
Interbody fusion was performed using i-factor + allograft.It was packed inside the disc space from right side without a cage as disc space was narrow and there was osteoporosis.30 hours after surgery, the patient walked in the hallway and she developed progressively worsening foot drop.Ct and mri showed this was secondary to i-factor as it retropulsed into the spinal canal on the left side (opposite the side it was introduced).The allograft was an unknown brand of cancellous allograft.Remedial action by the surgeon included revision surgery for removal of the i-factor from the spinal canal around the left l5 nerve root.The surgery resulted with prompt sensory return and slow improvement of foot drop.

• Brand Name: I-FACTOR PEPTIDE ENHANCED BONE GRAFT
• Common Device Name: BONE GRAFT
• Manufacturer (Section D): CERAPEDICS, INC.; 11025 dover st. suite 1600; westminster CO 80021
• MDR Report Key: 9321330
• Report Number: 3007155473-2019-00014
• Device Sequence Number: 14084465
• Product Code: NOX
• UDI-Device Identifier: M8517000501
• UDI-Public: +M8517000501/$$321083118C04935
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 700-050
• Device Catalogue Number: 700-050
• Device Lot Number: 18C0493
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 11/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 72 YR