BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANAX 5.5 SPINAL SYSTEM

    MDR report key: 10287041 · Received July 16, 2020

    Report

    Report Number
    9617297-2020-00004
    Event Type
    Malfunction
    Date Received
    July 16, 2020
    Date of Event
    May 19, 2020
    Report Date
    July 10, 2020
    Manufacturer
    U&I CORPORATION
    Product Code
    MNH
    PMA / PMN Number
    K132101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVERSE EVENT OCCURED IN (B)(6). BROKEN SCREW OF ANAX 5.5 SPINAL SYSTEM (POLYAXIAL SCREW) INSERTED IN MALE PATIENT'S SPINE L4-L5 ON (B)(6) 2019 WAS CONFIRMED AT (B)(6) HOSPITAL ON (B)(6) 2020. SO FAR, NO REVISION SURGERY HAS BEEN PERFORMED AND THE PATIENT'S CONDITION IS BEING MONITORED. WE HAVE REQUESTED INFORMATION FROM THE AGENCY SEVERAL TIMES TO CHECK PRODUCT, PATIENT, AND SURGICAL INFORMATION, BUT WE HAVE NOT RECEIVED IT SO FAR. AS A RESULT OF INVESTIGATING THE INFORMATION BELOW, IT IS DIFFICULT TO DECIDE IT AS AN ISSUE CAUSED BY A PRODUCT PROBLEM. AS A RESULT OF INVESTIGATING THE OCCURRENCE RATE OF THE SAME ISSUE, THE INCIDENCE RATE OF CUSTOMER COMPLAINT (FIRST ONE) COMPARED TO THE CUMULATIVE QUANTITY OF SALES (23,551EA) OF THE PRODUCT IS 0.004%. WE FOUND THAT THE FREQUENCY OF BREAKING THE PEDICLE SCREW IN THE RANGE OF APPROXIMATELY 3% TO 5.7% THROUGH A RESEARCH OF THE RELEVANT PAPER*. *OLIVER P. GAUTSCHI ET AL. CLINICALLY RELEVANT COMPLICATIONS RELATED TO PEDICLE SCREW PLACEMENT IN THORACOLUMBAR SURGERY AND THEIR MANAGEMENT A LITERATURE REVIEW OF 35,630 PEDICLE SCREWS, NEUROSURG FOCUS, 2011. IT IS DIFFICULT TO VERIFY THE MANUFACTURING HISTORY (LOT NO.) BECAUSE THE PRODUCT IS NOT REMOVED FROM THE PATIENT'S BODY.

    Description of Event or Problem · 1

    BROKEN SCREW OF ANAX 5.5 SPINAL SYSTEM (POLYAXIAL SCREW) INSERTED IN MALE PATIENT'S SPINE L4-L5 ON (B)(6) 2019 WAS CONFIRMED AT (B)(6) HOSPITAL ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746805 ANAX 5.5 SPINAL SYSTEM ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION MNH U&I CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other