BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM

    MDR report key: 6908611 · Received October 2, 2017

    Report

    Report Number
    1526439-2017-10784
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    September 1, 2017
    Report Date
    September 7, 2017
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    UDI-DI
    10705034084664
    PMA / PMN Number
    K160904
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED DEVICE FEATURED IRREGULAR WITNESS MARKS. 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. A TREND ANALYSIS WAS CONDUCTED. NO EMERGING TRENDS WERE FOUND REQUIRING FURTHER ACTIONS. THE ROOT CAUSE OF THE SET SCREWS LOOSENING COULD NOT BE DETERMINED BY THE SAMPLE OR INFORMATION PROVIDED. A POTENTIAL ROOT CAUSE MAY BE THE SET SCREWS NOT BEING FULLY TIGHTENED DOWN ONTO THE ROD. THIS COULD POTENTIALLY ALLOW A SET SCREW TO LOOSEN POSTOPERATIVELY. 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.

    Additional Manufacturer Narrative · 1

    DEVICE IS AVAILABLE FOR EXAMINATION. INVESTIGATION WILL BE CONDUCTED. FOLLOW UP WILL BE FILED WITH FINDINGS. 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

    TWO SET SCREWS OF TWO EXPEDIUM UNIVERSAL CONNECTORS WERE LOOSENED AND ONE GOT TOTALLY OFF ONE MONTH POSTOPERATIVELY AFTER REVISION SURGERY (DUE TO EARLIER BROKEN RODS). AND ONE POLYAXIAL SCREW HEAD OF ONE EXPEDIUM 6.35 POLYAXIAL SCREW GOT OFF WHEN REMOVING THE SCREW WITH THE CORRESPONDING SCREW DRIVER. RODS WILL ALSO BE SENT TO INVESTIGATION. WHAT MIGHT HAVE CAUSED THE LOOSENING OF THE SET SCREWS? THESE PRODUCTS ARE ALSO A PART OF THIS COMPLAINT: EXP SET SCREW 6.35, CATALOG 179902000, LOT ARBC68,1 EA, WILL BE RETURNED EXP 6.35 SCREW POLY 6.0X45, CATALOG 179902000, LOT 133674, 2 EA, WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688687 EXPEDIUM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE 179902000 133674 10705034084664

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention