BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM SINGLE-INNER SETSCREW

    MDR report key: 3073142 · Received April 23, 2013

    Report

    Report Number
    1526439-2013-15760
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 28, 2013
    Report Date
    May 17, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK033901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    EXAMINATION OF THE RETURNED SET SCREW FOUND THAT ITS THREADS WERE STRIPPED. ALTHOUGH THE CAUSE OF THREAD STRIPPING CANNOT BE POSITIVELY DETERMINED, THE DAMAGE WAS MOST LIKELY CAUSED BY AN UNANTICIPATED AXIAL STRESS LOAD OF THE INSERTION OF A PEDICLE SCREW DURING THE PROCEDURE. REVIEW OF THE DEVICE HISTORY RECORD FOUND NO ISSUES WERE IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD HAVE BEEN ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY REQUIREMENTS. IN THE ABSENCE OF A PRODUCT ISSUE OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE QUICK CONNECT POLYAXIAL SCREWDRIVER BROKE OFF FROM THE INSTRUMENT DURING POLY SCREW INSERTION. THE BROKEN TIP WAS RETRIEVED. WHEN ATTEMPTING TO DRIVE THE SCREW ALL THE WAY IN, THE HEAD OF THE POLYAXIAL SCREW SEPARATED FROM ITS SHANK. THE SURGEON AS UNABLE TO BACK OUT THE SCREW SHANK AND DECIDED TO PLACE ANOTHER SCREW NEXT TO THE BROKEN SHANK. AT THE END OF THE CASE, THE THREADS OF A SET SCREW TORN AWAY FROM THE DEVICE DURING TIGHTENING OF THE DEVICE. THE DAMAGED SET SCREW AND ITS TORN THREADS WERE REMOVED FROM THE SITE AND ANOTHER SET SCREW WAS INSERTED WITHOUT ISSUE. THIS REPORT IS BEING FILED FOR THE SET SCREW WITH THREADS THAT WERE TORN. SEE MFG MEDWATCH REPORT NO. 1526439-2013-15759, FOR THE POLYAXIAL SCREW DRIVER THAT WAS INVOLVED IN THIS EVENT. SEE MFG MEDWATCH REPORT NO. 1526439-2013-15762, FOR THE POLYAXIAL SCREW THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173549 EXPEDIUM SINGLE-INNER SETSCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE ANPCV2

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR