BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM TI POLYAXIAL SCREW 9MMX55MM

    MDR report key: 3251246 · Received July 29, 2013

    Report

    Report Number
    1526439-2013-22287
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 8, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK101993
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION. UNABLE TO RETRIEVE FROM HOSP.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED ON (B)(6) "20013" THAT THE SURGEON PLACED THE SCREW TO SCREW DISTRACTION RACK ON THE TWO EXPEDIUM SCREW HEADS AND WHEN HE WENT TO DISTRACT THE SCREWS WHEN THE POLYAXIAL HEAD OF THE 9MM X 55MM SCREW CAME OFF. THE SURGEON GATHERS THE HEAD, REMOVED THE BONE SCREW AND CONTINUED ON WITH THE SURGERY. IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREW HEAD SEPARATED FROM THE SCREW SHANK INTRA-OPERATIVELY WHEN DISTRACTION WAS PERFORMED DURING A TRANSFORAMINAL LUMBAR INTERBODY FUSION PROCEDURE. THE SURGEON REMOVED AND REPLACED THE SCREW AND CONTINUED WITH THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352669 EXPEDIUM TI POLYAXIAL SCREW 9MMX55MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR