BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPEDIUM SI POLYAXL SCREW 4.35 X 40MM

    MDR report key: 3232669 · Received July 18, 2013

    Report

    Report Number
    1526439-2013-21340
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    NKB
    PMA / PMN Number
    PK033901
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE DEVICE HISTORY RECORD CANNOT BE PERFORMED AS THE LOT CODE IS UNKNOWN. A REVIEW OF THE COMPLAINT TREND ANALYSIS FOUND NO RELATED COMPLAINTS OF THIS NATURE IN THE LAST TWELVE MONTHS THAT WERE ASSOCIATED WITH THIS PRODUCT CODE. NO DEFINITIVE CONCLUSIONS CAN BE MADE AS TO THE CAUSE OF SCREW BREAKAGE. HOWEVER, IT IS POSSIBLE THAT THE PATIENT¿S ACTIVITY LEVEL AND PREVIOUS BURST FRACTURE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. WITHOUT A PRODUCT SAMPLE, WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE, AND 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 PRODUCT EVALUATED.

    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 THAT THE ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2012 FOR AN L2 BURST FRACTURE WITH SPINAL CANAL EFFACEMENT AND NERVE ROOT COMPRESSION. THE PATIENT RETURNED TO THE O.R. ON (B)(6) 2013 TO HAVE THE HARDWARE REMOVED. UPON REMOVAL, THE TWO PEDICLE SCREWS AT T12 AND ONE ON THE RIGHT OF L1 WERE BROKEN AT THE TULIP/SHANK INTERFACE. ALL SCREWS FROM T12-L4 WERE REMOVED, LEAVING THE THREE BROKEN SHANKS IN T12 AND L1 ON THE RIGHT. SEE MFG MEDWATCH REPORT NO. 1526439-2013-21339 FOR THE FIRST SCREW THAT WAS INVOLVED IN THIS EVENT. SEE MFG MEDWATCH REPORT NO. 1526439-2013-21341 FOR THE THIRD SCREW THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334491 EXPEDIUM SI POLYAXL SCREW 4.35 X 40MM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention