BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPRO SPINAL JAXX

    MDR report key: 15940090 · Received December 8, 2022

    Report

    Report Number
    3013378904-2022-00001
    Event Type
    Injury
    Date Received
    December 8, 2022
    Date of Event
    October 25, 2022
    Report Date
    December 8, 2022
    Manufacturer
    NEUROPRO SPINAL JAXX
    Product Code
    MAX
    UDI-DI
    00818956021006
    PMA / PMN Number
    K152501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SURGEON PERFORMED A SURGERY ON (B)(6) 2022 IN WHICH HE IMPLANTED A SPINAL JAXX IMPLANT, EVERYTHING WENT FINE. THE PATIENT DID GREAT FOR A FEW WEEKS AFTER THE SURGERY, AND THEN DEVELOPED SEVERE LEG PAIN. SURGEON OBTAINED IMAGING STUDIES THAT SHOWED THE IMPLANT HAD BACKED OUT INTO THE CANAL. ON (B)(6) 2022, SURGEON PERFORMED A FOLLOW UP SURGERY WHICH WENT WELL, AFTER WHICH THE PATIENT FELT COMPLETE RELIEF. NOTHING WAS WRONG WITH THE IMPLANT AND SURGEON ATTRIBUTED THE BACKING OUT TO SURGEON ERROR DURING THE FIRST SURGERY. THE IMPLANT WAS REMOVED DURING THE SECOND SURGERY AND A NEW SPINAL JAXX IMPLANT WAS INSERTED DEEPER INTO THE INTERBODY SPACE. EVERYTHING HAS SEEMED FINE SINCE THEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2260999 NEUROPRO SPINAL JAXX INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX NEUROPRO SPINAL JAXX 100001-627 191224I 00818956021006

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Hospitalization| R