BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM SI POLYAXIAL SCREW

    MDR report key: 2678044 · Received August 1, 2012

    Report

    Report Number
    1526439-2012-00169
    Event Type
    Malfunction
    Date Received
    August 1, 2012
    Date of Event
    July 3, 2012
    Report Date
    August 1, 2012
    Manufacturer
    DEPUY RAYNHAM
    Product Code
    NKB
    PMA / PMN Number
    K033901
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEFINITIVE CONCLUSIONS CAN BE MADE AS THE POLYAXIAL SCREW WAS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. THE LOT CODE OF THE DEVICE IS UNKNOWN. COMPLAINT DATA IS REVIEWED MONTHLY BY CROSS FUNCTIONAL GROUPS WITHIN THE COMPANY TO ENSURE A ROBUST REVIEW. COMPLAINT DATA REVIEW FOUND NO EMERGING TRENDS. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED. DEVICE IMPLANTED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS INSTRUMENTATION WAS PERFORMED WITH EXPEDIUM SI POLYAXIAL SCREWS FOR SPINAL CANAL STENOSIS, DEGENERATIVE SPONDYLOLISTHESIS AND SCOLIOSIS. THE SURGEON PLACED A ROD ON THE POLYAXIAL SCREW HEAD AND A SET SCREW WAS TIGHTENED SECURELY. HOWEVER, THE HEAD OF THE POLYAXIAL SCREW MOVED AND WAS NOT STATIONARY/FIXED. REPORTS THAT AS A RESULT, THE SURGEON COULD NOT APPLY THE STRONG CORRECTION AND FELT THE SCREW HEAD WAS NOT FIXED STRONGLY. THE SURGEON MADE THE DECISION TO KEEP THE SCREW IN PLACE TO AVOID EXTENDING THE SURGERY TIME BY REMOVING AND REPLACING THE SCREW. REPORTS THE CONSTRUCT WAS COMPLETED WITH NO HEALTH ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM SI POLYAXIAL SCREW ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB DEPUY RAYNHAM UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 EXPEDIUM SET SCREW, (B)(4)| EXPEDIUM ROD, CATALOG# UNKNOWN