BEUDAMED
    FDA Adverse Event Injury Summary report: N

    I-FACTOR PEPTIDE ENHANCED BONE GRAFT

    MDR report key: 9321330 · Received November 14, 2019

    Report

    Report Number
    3007155473-2019-00014
    Event Type
    Injury
    Date Received
    November 14, 2019
    Date of Event
    November 15, 2018
    Report Date
    November 12, 2019
    Manufacturer
    CERAPEDICS, INC.
    Product Code
    NOX
    UDI-DI
    M8517000501
    PMA / PMN Number
    P140019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117416 I-FACTOR PEPTIDE ENHANCED BONE GRAFT BONE GRAFT NOX CERAPEDICS, INC. 700-050 18C0493 M8517000501

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R