BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT SET SCREW.

    MDR report key: 2858004 · Received December 5, 2012

    Report

    Report Number
    1526439-2012-00297
    Event Type
    Injury
    Date Received
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    KWP
    PMA / PMN Number
    K030103
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO LOT NUMBER OR SAMPLE WAS AVAILABLE. WITHOUT A LOT NUMBER, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. COMPLAINT DATA IS REVIEWED MONTHLY VIA THE SPINE MONTHLY COMPLAINT REVIEW MEETING TO IDENTIFY AND INITIATION ACTION AGAINST ANY EMERGING TRENDS; THE MEETING INCLUDES CROSS FUNCTIONAL REPRESENTATION FROM RD, QUALITY ENGINEERING, CLINICAL RESEARCH, AND COMPLAINT HANDLING TO ENSURE A ROBUST REVIEW. NO TRENDS WERE NOTED. IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS A SUMMIT BONE SCREW WAS INITIALLY IMPLANTED AND IT WAS NOTED THAT A LITTLE WASHER/SET SCREW WAS ON THE FIELD. THE SCREW WAS EXPLANTED AND REPLACED BY ANOTHER SCREW WITH NO ADVERSE CONSEQUENCES TO THE PATIENT. IT APPEARS THAT THE COMPLAINT WAS REPORTED DUE TO SEPARATION AND MIGRATION OF A SUMMIT INNER SET SCREW, RESULTING IN THE NEED FOR REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT SET SCREW. APPLIANCE, FIXATION, SPINAL INTERLAMINAL KWP DEPUY RAYNHAM

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MFA BONE SCREW: (B)(4)