BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM SINGLE-INNER SETSCREW

    MDR report key: 3151581 · Received June 7, 2013

    Report

    Report Number
    1526439-2013-18377
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 29, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK033901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON RECEIPT OF THE DEVICE AND COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION FOUND NO VISUAL ANOMALIES WITH THE SET SCREW. MOREOVER, THERE WAS NO NOTED DAMAGE WITH THE RETURNED SET SCREW AS REPORTED IN THE COMPLAINT EVENT DESCRIPTION. A DEVICE HISTORY RECORD (DHR) REVIEW IDENTIFIED NO ISSUES DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO TRENDS FOR ISSUES OF THIS NATURE. THE ROOT CAUSE IS UNKNOWN AS THERE WAS NO PRODUCT PROBLEM IDENTIFIED. NO CORRECTIVE ACTION IS REQUIRED AS THERE HAS BEEN NO ISSUE IDENTIFIED IN THE MANUFACTURING OR RELEASE OF THE DEVICE AND THERE HAS BEEN NO OBSERVED SYSTEMIC TREND. THEREFORE, THE COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE SET SCREW BECAME CRACKED DURING INSERTION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO DELAY AS ANOTHER SET SCREW WAS AVAILABLE FOR USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252280 EXPEDIUM SINGLE-INNER SETSCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE APBBHZ

    Patients

    Seq Age Sex Outcome Treatment
    1