BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEURO SPONGE PATTIES

    MDR report key: 14168337 · Received April 21, 2022

    Report

    Report Number
    1060680-2022-00002
    Event Type
    Malfunction
    Date Received
    April 21, 2022
    Date of Event
    February 23, 2022
    Report Date
    June 24, 2022
    Manufacturer
    DEROYAL INDUSTRIES, INC.
    Product Code
    EFQ
    UDI-DI
    00749756037808
    PMA / PMN Number
    K791871
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FIRST COMPLAINT OF THIS TYPE FOR THIS PRODUCT GROUP. THERE HAVE BEEN 5 TOTAL COMPLAINTS REPORTED FOR THIS PRODUCT GROUP SINCE APRIL 2020 FOR A COMPLAINT RATE OF 0.328%. THIS INVESTIGATION IS ONGOING AND ROOT CAUSE HAS YET TO BE DETERMINED. A SCAR HAS BEEN INITIATED AND A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 6/1/2022 WITH THE COMPLETION OF THE REQUESTED SCAR. MANUFACTURING RECORDS INCLUDING NON-CONFORMANCE LOGS AND COMPLAINT LOGS FROM 2019 TO 2022 WERE REVIEWED AND THIS WAS FOUND TO BE THE FIRST EVENT OF THIS TYPE, WITH NO HISTORY OF SIMILAR DEFECTS. AS THE LOT NUMBER OF THE REPORTED PRODUCT WAS NOT AVAILABLE, A CASE OF ANOTHER LOT WAS PULLED FOR TESTING BY THE SUPPLIER. THIRTY SPONGES WERE TESTED IN WATER SOAKING OVERNIGHT AND FOUND TO HAVE NO DISCREPANCIES. AN UNDER WATER PULL TEST WAS PERFORMED ON 20 SPONGES AND NO DISCREPANCIES WERE FOUND. ROUGH HANDLING AND PULLING TESTS WERE PERFORMED ON THE REST OF CASE WITH NO DISCREPANCIES. THE INVESTIGATION PERFORMED BY THE SUPPLIER FOR THE SCAR IDENTIFIED NO DISCREPANCIES AND A ROOT CAUSE WAS NOT ABLE TO BE DETERMINED. THIS WAS ASSESSED TO BE A SINGLE ISOLATED INCIDENT AND THEREFORE NO CORRECTIVE ACTIONS WERE TAKEN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVILABLE.

    Description of Event or Problem · 0

    (B)(4) 1/4 X 1/4 NEURO PATTIES WERE USED. THE SURGICAL TECHNOLOGIST NOTED THAT THE X-RAY DETECTABLE LINE IN A PATTY HAD FALLEN OFF ONTO THE SURGICAL BACK TABLE AFTER THE PATTY WAS REMOVED FROM THE PATIENT. PROCEDURE: LUMBAR LAMINECTOMY, NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769671 NEURO SPONGE PATTIES NEURO SPONGE PATTIES EFQ DEROYAL INDUSTRIES, INC. 30-154 00749756037808

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown