BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUMMIT BONE SCREW, 3.5 X 20MM

    MDR report key: 3120338 · Received May 20, 2013

    Report

    Report Number
    1526439-2013-17373
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 9, 2013
    Report Date
    May 21, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    MNI
    PMA / PMN Number
    PK030103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SCREW WAS RETURNED WITHOUT ITS INNER SADDLE COMPONENT. EXAMINATION OF THE RETURNED DEVICE UNDER 10X MAGNIFICATION DETERMINED THAT THE TULIP HEAD COMPONENT HAD BEEN SUBJECTED TO THE SWAGING PROCESS AS REQUIRED. NO VISUAL ANOMALIES WERE NOTED DURING THIS INSPECTION. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. REVIEW OF PRODUCT COMPLAINTS FOUND NO EMERGING TRENDS. ALTHOUGH NO DEFINITIVE CONCLUSIONS CAN BE MADE, THE INNER SADDLE WAS MOST LIKELY SUBJECTED TO AN UNANTICIPATED SIDE LOADING, RESULTING IN INNER SADDLE DISLODGEMENT. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE BONE SCREW¿S INNER SADDLE COMPONENT SEPARATED FROM THE SCREW INTRA-OPERATIVELY DURING SCREW INSERTION. ANOTHER SCREW WAS AVAILABLE TO BE PLACED WITH NO ADVERSE CONSEQUENCES AND WITHOUT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221780 SUMMIT BONE SCREW, 3.5 X 20MM ORTHOSIS, SPINAL PEDICLE FIXATION MNI DEPUY SYNTHES SPINE R000260

    Patients

    Seq Age Sex Outcome Treatment
    1