BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUM MONOAXIAL SCREW 6 X 40 MM

    MDR report key: 2020538 · Received February 10, 2011

    Report

    Report Number
    1526439-2011-00010
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    January 15, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MNH
    PMA / PMN Number
    K062174
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONTACT CONFIRMED THAT THE SAMPLES ARE UNAVAILABLE FOR EVAL AT THIS TIME. THERE WAS AN ERROR WHEN SHIPPING THE PRODUCTS TO (B)(6) WHICH HAS RESULTED IN THE IMPLANTS BECOMING LOST IN TRANSIT. AFFILIATE HAS ATTEMPTED TO TRACK DOWN THE IMPLANTS WITHOUT SUCCESS. THE LOT NUMBERS ARE UNK, THEREFORE, A DEVICE HISTORY RECORDS REVIEW CANNOT BE PERFORMED. NO CONCLUSION CAN BE MADE AT THIS TIME. BASED ON THE DESCRIPTION OF THE EVEN, IT IS LIKELY THAT THE SETSCREW MAY HAVE BEEN CROSS THREADED ON THE SCREW HEAD RESULTING IN DAMAGE TO THE MATING THREADS. THE POTENTIAL EXISTS FOR SETSCREW CROSS-THREADING AND/OR STRIPPING IN THE EXPEDIUM SPINE SYS DUE TO IMPROPER ALIGNMENT OF THE SETSCREW AND/OR MEDIAL/LATERAL FORCES BEING APPLIED DURING FINAL TIGHTENING. THE USE OF THE SCREW ALIGNMENT GUIDE AND ROD STABILIZER AS RECOMMENDED IN THE SURGICAL TECHNIQUE WILL HELP TO MITIGATE THIS PROBLEM.

    Description of Event or Problem · 1

    CONTACT REPORTED THE SCREW AND SETSCREWS WERE DAMAGED DURING INSERTION. SURGEON USED ANOTHER SCREW DURING PROCEDURE. THE SURGEON USES ONLY MONOAXIAL SCREWS AND THE SIZE HE NEEDED WAS NOT AVAILABLE. THIS CAUSED THE DELAY IN SURGERY IN EXCESS OF 30 MINS. AS SUCH, A REPORT IS FILED TO DOCUMENT THIS EVENT. DEVICE 1: SEE ALSO MDR 1526439-2011-00011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPEDIUM MONOAXIAL SCREW 6 X 40 MM SPINAL FIXATION DEVICE MNH DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK