BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLE/SWIFT PLUS, SCREW PRM, SD, 12MM

    MDR report key: 3042470 · Received April 9, 2013

    Report

    Report Number
    1526439-2013-15100
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 13, 2013
    Report Date
    April 2, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    KWQ
    PMA / PMN Number
    PK070994
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL INSPECTION NOTED THAT THE THREADS OF THE SCREW HAD BEEN CRUSHED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD¿VE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. ALTHOUGH NO DEFINITIVE CONCLUSIONS CAN BE MADE, THE DAMAGE SUGGESTS THAT UPON ENGAGING SCREW INTO THE CONCOMITANT DEVICE PLATE, THE SCREW WAS NOT PROPERLY ALIGNED (OFF CENTER), CAUSING THREAD DEFORMATION UPON ENGAGING IN TO THE HOLE OF THE PLATE. 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 COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO DEPUY SYNTHES SPINE THAT DURING SCREW INSERTION, THREADS PEELED FROM THE SCREW AS A RESULT OF CONTACT WITH THE BUSHING OF AN EAGLE SWIFT CERVICAL PLATE. THE PEELED/TORN THREADS WERE STILL ATTACHED TO THE SCREW WHICH WAS REMOVED AND REPLACED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO SIGNIFICANT DELAY. CONCOMITANT DEVICE: EAGLE SWIFT CERVICAL PLATE, CATALOG NO. UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147279 EAGLE/SWIFT PLUS, SCREW PRM, SD, 12MM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ DEPUY SYNTHES SPINE ANKBVF

    Patients

    Seq Age Sex Outcome Treatment
    1