BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER TI SAI POLY 9X90MM

    MDR report key: 7752082 · Received August 6, 2018

    Report

    Report Number
    1526439-2018-50737
    Event Type
    Injury
    Date Received
    August 6, 2018
    Date of Event
    June 5, 2018
    Report Date
    June 12, 2018
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NKB
    UDI-DI
    10705034265865
    PMA / PMN Number
    K160904
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION FOUND THAT THE THREADS ON THE POLY SCREW¿S TULIP HEAD HAD BECOME TORN OFF. 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. ALL COMPLAINT TRENDS WILL BE EVALUATED AS A PART OF THE DEPUY SPINE MONTHLY COMPLAINT REVIEW MEETING. A DEFINITIVE ROOT CAUSE FOR THE TULIP HEAD THREADS BECOMING TORN OFF CANNOT BE POSITIVELY DETERMINED. HOWEVER, NOTED DAMAGE SUGGESTS THAT INADVERTENTLY CROSS THREADING OCCURRED. 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 AND NO SYSTEMIC TRENDS WERE FOUND, 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

    SCREW WAS INSERTED WITH CORRECT SCREW DRIVER AND NO ISSUES. ROD WAS PLACED IN CONSTRUCT AND LOCKING CAPS WERE INSERTED. THE LOCKING CAPS FOR THE SAI SCREW COULD NOT BE TIGHTENED ALTHOUGH ROD SEEMED TO BE SEATING WELL IN SCREW HEAD. A SECOND LOCKING CAP WAS TAKEN TRYING AGAIN TO LOCK IT. THE IT WAS REALIZED THAT THE ISSUE WAS WITH THE SCREW AND NOT THE LOCKING CAP. ACCORDINGLY THE SCREW WAS REPLACED WITH A NEW ONE AND EVERYTHING COULD BE COMPLETED WITHOUT A PROBLEM. PATIENT CONSEQUENCE?: NO. ACTION TAKEN FOR PROCEDURE:NEW SCREW WAS INSERTED. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596011 VIPER TI SAI POLY 9X90MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDOS INTERNATIONAL SàRL CH 179704990 TBTZK 10705034265865

    Patients

    Seq Age Sex Outcome Treatment
    1