BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER TI SAI POLY 9X100MM

    MDR report key: 8734465 · Received June 26, 2019

    Report

    Report Number
    1526439-2019-51801
    Event Type
    Injury
    Date Received
    June 26, 2019
    Report Date
    June 11, 2019
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034265889
    PMA / PMN Number
    K111571
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH THE INVESTIGATION RESULTS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT (B)(4). UDI (B)(4). THE SCREW FEATURES SIGNS OF USE SUCH AS SURFACE MARKINGS AND WEAR TO THE DRIVE FEATURE OF THE SCREW. HOWEVER, THE SCREW FEATURED NO SIGNS OF LOOSENING. NO POSTOPERATIVE X-RAYS WERE PROVIDED TO CONFIRM THE PEDICLE SCREW LOOSENING. THE LOOSENING CANNOT BE REPLICATED. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED. NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE ROOT CAUSE OF THE POLY SCREW LOOSENING POSTOPERATIVELY CANNOT BE DETERMINED FROM THE SAMPLE AND INFORMATION PROVIDED. A POTENTIAL ROOT CAUSE CANNOT BE DETERMINED SINCE THE REPORT OF THE SCREW LOOSENING COULD NOT BE CONFIRMED OR REPLICATED. AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE THAT COULD HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER, THIS COMPLAINT FILE WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. 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

    IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING REVISION, THE ROD BREAK BOTH SIDES. AFTER CHECKING THE SACRAL ALAR ILIAC (SAI) SCREWS, IT WAS FOUND THAT ONE SCREW DOES NOT HOLD WELL IN THE BONE LIKE THE OTHER AND WAS REPLACED, METALLOSE WERE DETECTED IN THE AREA OF THE REPLACED SCREW. SURGICAL DELAY AND PROCEDURE OUTCOME ARE UNKNOWN. THERE WAS PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES TWO (2) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530222 VIPER TI SAI POLY 9X100MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDOS INTERNATIONAL SàRL CH 179704999 TBWRD 10705034265889

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention