BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LONGITUDE ROD

    MDR report key: 10325043 · Received July 27, 2020

    Report

    Report Number
    1030489-2020-00977
    Event Type
    Malfunction
    Date Received
    July 27, 2020
    Date of Event
    July 3, 2020
    Report Date
    July 27, 2020
    Manufacturer
    WARSAW ORTHOPEDICS
    Product Code
    KWP
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT MARKETED IN US.PMA 510K NO. IS K121680 FOR SIMILAR DEVICE MARKETED IN US WITH PRODUCT ID AS 1475006500. PRODUCT IS NOT RETURNED AT THE TIME OF THIS REPORT. ANALYSIS REPORT WILL BE ATTACHED TO SUPPLEMENTAL REPORT ONCE PRODUCT IS RECEIVED BACK AND ANALYSED. . IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH PRE-OPERATIVE DIAGNOSIS OF PRESSURE ULCER. IT WAS REPORTED THAT PATIENT HAD SYMPTOMS OF PRESSURE ULCER DUE TO THAT THE ROD WAS BROKEN AND BA NUT CAME OFF POST INITIAL SURGERY DONE ON JULY 30,2019. HENCE REVISION SURGERY IS PLANNED . DURING REVISION SURGERY, IT IS FOUND THAT SET SCREW WAS BROKEN AND NUT CAME OFF FOR BREAK OFF SET SCREW AND MULTI-AXIAL SCREW. THE SCREW WAS REMOVED AND DEBRIDEMENT WAS PERFORMED. PATIENT ACHIEVED SOLID FUSION. DEVICE IS EXPLANTED AND IT WILL BE RETURNED. THERE WERE PATIENT SYMPTOMS OR COMPLICATIONS AS A RESULT OF THIS EVENT. PRESSURE ULCER DEVELOPED ON THE LEFT OF S2AI. THE ROD WAS BROKEN AT JUST ABOVE THE RIGHT L5. THE NUT CAME OFF AT LEFT S2AI, WHICH CAUSED PRESSURE ULCER. IN THE RE-OPERATION, DEBRIDEMENT WAS PERFORMED FOR THE PRESSURE ULCER PART, AND RESECTION WAS ALSO PERFORMED. LOOSENING OF THE SCREW AT RIGHT S1 AND TWO SCREWS AT S2 WAS CONFIRMED DURING THE RE-OPERATION. THERE WAS NO INFORMATION ABOUT THE OCCURRENCE OF NEUROLOGICAL SYMPTOM FROM THE PATIENT. ACCORDING TO THE PHYSICIAN'S OPINION, IT WAS SAID THAT THE ROD WAS BROKEN AND IT BECAME UNBEARABLE, AND THE NUT CAME OFF. TYPE OF PROCEDURE IS SCREW REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791737 LONGITUDE ROD APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP WARSAW ORTHOPEDICS 1554106500 0585941W

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention