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U.S. Department of Health and Human Services

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

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CERAPEDICS, INC. I-FACTOR PEPTIDE ENHANCED BONE GRAFT Back to Search Results
Model Number 700-050
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Nerve Damage (1979)
Event Date 11/15/2018
Event Type  Injury  
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 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.
 
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Brand Name
I-FACTOR PEPTIDE ENHANCED BONE GRAFT
Type of Device
BONE GRAFT
Manufacturer (Section D)
CERAPEDICS, INC.
11025 dover st. suite 1600
westminster CO 80021
Manufacturer (Section G)
CERAPEDICS, INC.
11025 dover st. suite #1600
westminster CO 80021
Manufacturer Contact
mark bowerman
11025 dover st. suite #1600
westminster, CO 80021
3039746275
MDR Report Key9321330
MDR Text Key166357661
Report Number3007155473-2019-00014
Device Sequence Number1
Product Code NOX
UDI-Device IdentifierM8517000501
UDI-Public+M8517000501/$$321083118C04935
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P140019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 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
Device Operator Health Professional
Device Expiration Date08/31/2021
Device Model Number700-050
Device Catalogue Number700-050
Device Lot Number18C0493
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/10/2018
Initial Date FDA Received11/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age72 YR
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