BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIPER TI SAI POLY 8X80MM

    MDR report key: 7864024 · Received September 11, 2018

    Report

    Report Number
    1526439-2018-50858
    Event Type
    Injury
    Date Received
    September 11, 2018
    Report Date
    August 13, 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
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). RETURNED DEVICE WAS SENT FOR FRACTURE ANALYSIS. THE SCREW FRACTURE SURFACES IMAGE DOES NOT SUGGEST FATIGUE FRACTURE AS CHARACTERISTIC FATIGUE STRIATIONS ARE ABSENT. THE SURFACES SHOW HIGHLY IRREGULARLY SHAPED FACES FROM EITHER DUCTILE FAILURE AND/OR IN VIVO FRETTING. THE BOTTOM PART OF THE SHANK DISPLAYS APPARENT DAMAGE TO THE FRACTURE SURFACE AND EXTERNAL THREADS CONSISTENT WITH TOOL MARKS INFLICTED DURING SHANK REMOVAL POST FRACTURE. 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 POST-OPERATIVE BREAKING OF THE REPORTED POLY-AXIAL SCREW CANNOT BE DETERMINED. FRACTURE ANALYSIS OF THE SCREW SUGGESTS THAT SURFACES SHOW HIGHLY IRREGULARLY SHAPED FACES FROM EITHER DUCTILE FAILURE AND/OR IN VIVO FRETTING. SURFACES ALSO DISPLAY APPARENT DAMAGE TO THE FRACTURE SURFACE AND EXTERNAL THREADS CONSISTENT WITH TOOL MARKS INFLICTED DURING SHANK REMOVAL POST FRACTURE. 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

    IT WAS REPORTED THAT THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2015 BY USING EXPEDIUM PLUS SPINE SYSTEM FOR SACROILIAC JOINT. ON (B)(6) 2018, THE PATIENT COMPLAINED THE PAIN AT SACROILIAC JOINT, SO THAT THE SURGEON FOUND THAT THE REPORTED SCREW WAS BROKEN UNDER X-RAY (IT WAS UNKNOWN WHEN THE BREAKAGE WAS OCCURRED). IT WAS REPORTED THAT THE ONLY BROKEN SCREW WAS EXPLANTED ON (B)(6) 2018 FROM THE PATIENT¿S SACROILIAC JOINT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705413 VIPER TI SAI POLY 8X80MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MEDOS INTERNATIONAL SàRL CH 179704880 TBIXT 10705034265728

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention