BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSPAN

    MDR report key: 11071937 · Received December 23, 2020

    Report

    Report Number
    MW5098523
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    August 19, 2020
    Report Date
    December 22, 2020
    Manufacturer
    INSPAN LLC/ KICVENTURES / SPINEFRONTIER, INC. DBA LESSPINE INNOVATIONS
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    NOT ENOUGH ROOM; ON (B)(6) 2020 PREFERRED (B)(4). AN INSPAN DEVICE MANUFACTURED AND SOLD BY INSPAN LLC WAS BEING IMPLANTED. UPON "LOCKING OF THE INSTRUMENT" THE TOOL USED TO LOCK THE DEVICE REACHED NEAR FAILURE. AT THE TIME KINGSLEY CHIN (OWNER OF INSPAN) AND HIS CLINICAL PARTNER INSTRUCTED ME TO RETRIEVE A NEW TOOL FROM ANOTHER LOCATION IN FEAR THAT THE TOOL ON HAND WOULD FAIL. THIS WOULD HAVE RESULTED IN THE PATIENT BEING ANESTHETIZED FOR AN ADDITIONAL MINIMUM OF 2 HOURS. WHILE GOING TO GO RETRIEVE THE NEW TOOL I WAS CALLED AND TOLD THAT THEY WERE IN FACT ABLE TO COMPLETE THE PROCEDURE WITH THE TOOL ON HAND. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1533369 INSPAN APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP INSPAN LLC/ KICVENTURES / SPINEFRONTIER, INC. DBA LESSPINE INNOVATIONS 58M70

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other