BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM SINGLE-INNER SETSCREW

    MDR report key: 3041427 · Received April 8, 2013

    Report

    Report Number
    1526439-2013-15072
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK033901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE RETAINED BY THE SURGEON AND WERE NOT RETURNED FOR EVALUATION.REVIEW OF THE DEVICE HISTORY RECORD(S) COULD NOT BE CONDUCTED AS THE LOT NUMBERS OF THE DEVICES WERE UNKNOWN. EXAMINATION OF X-RAY IMAGES FOUND A SET SCREW APPEARED TO BE DETACHED AT THE LATERAL ASPECT OF THE ROD AND SCREW CONSTRUCT. HOWEVER, LEVELS ARE INDETERMINATE BASED UPON THIS LIMITED VIEW AND NO DEFINITIVE CONCLUSIONS CAN BE MADE. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO OBSERVED TRENDS FOR ISSUES OF THIS NATURE. THE ROOT CAUSE IS UNDETERMINED. IN THE ABSENCE OF AN IDENTIFIED DEVICE MANUFACTURING/RELEASE ISSUE OR AN 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. DEVICE RETAINED BY CUSTOMER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO DEPUY SYNTHES SPINE THAT THE PATIENT WENT TO THE SURGEON FOR POST OPERATIVE VISIT WITH COMPLAINT OF CONTINUED BACK PAIN. X-RAYS ARE REPORTED TO HAVE REVEALED HARDWARE FAILURE. REVISION SURGERY FOUND DISPLACEMENT OF TWO SET SCREWS AND LOOSENING OF FIVE SET SCREWS OF THE CONSTRUCT. ALL SET SCREWS WERE REMOVED, REPLACED, AND RETIGHTENED. THIS REPORT IS BEING FILED FOR ONE EVENT INVOLVING SEVEN SET SCREWS THAT WERE FOUND TO HAVE BEEN DISPLACED AND LOOSENED. ALL ARE CATALOG NO. 179702000, LOT NUMBERS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143503 EXPEDIUM SINGLE-INNER SETSCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention