BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER TI SAI POLY 8X80MM

    MDR report key: 7784113 · Received August 15, 2018

    Report

    Report Number
    1526439-2018-50789
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    January 1, 2017
    Report Date
    July 25, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034265728
    PMA / PMN Number
    K111571
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A COMPLAINT INVESTIGATION WILL BE PERFORMED. THE COMPLAINT PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. A SUPPLEMENTAL REPORT IS NOT ANTICIPATED UNLESS THE RESULTS OF THE COMPLAINT INVESTIGATION IDENTIFY A CORRECTIVE ACTION OR ADDITIONAL RELEVANT INFORMATION. SHOULD THE PRODUCT BECOME AVAILABLE, A PHYSICAL EVALUATION WILL BE CONDUCTED AND A SUPPLEMENTAL REPORT FILED WITH THE RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE TLIF SURGERY FOR ADULT SPINAL DEFORMITY (ASD) WAS PERFORMED BY USING THE EXPEDIUM PUS SYSTEM (SACRAL-ALAR-ILIAC FIXATION). THE FIXED SITE WAS S2 AI. ON (B)(6) 2018, IT WAS REPORTED THAT THE SCREW (179704880, PART#: UNK) HAD BEEN BROKEN IN THE SACROILIAC JOINT, WHICH WAS NOTICED LATER THROUGH THE X-RAY PHOTOS TAKEN AROUND THREE MONTHS AFTER THE TLIF SURGERY. THE (B)(6) MALE PATIENT HAS A PAIN ON THE OPPOSITE SIDE OF THE SITE WHERE THE SCREW IN QUESTION WAS BROKEN. NO CAUSAL RELATION WAS REPORTED BETWEEN THE BROKEN SCREW AND THE SITE WHERE HE FEELS A PAIN. NO FURTHER INFORMATION HAS BEEN PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627214 VIPER TI SAI POLY 8X80MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDOS INTERNATIONAL SàRL CH 179704880 10705034265728

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other