BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONARCH PEDICLE SCREW

    MDR report key: 2191229 · Received July 29, 2011

    Report

    Report Number
    1526439-2011-00133
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 5, 2011
    Manufacturer
    DEPUY SPINE, INC.
    Product Code
    MNI
    PMA / PMN Number
    K10576
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVAL. NO CONCLUSION CAN BE MADE AT THIS TIME. THE DEVICE IS INTENDED TO BE A TEMPORARY FIXATION DEVICE TO AID IN THE PROCESS OF FUSION. BREAKAGE CAN OCCUR DUE TO DELAYED UNION OR NON-UNION AS WELL AS WITH CYCLICAL LOADING OF THE DEVICE OVER TIME. NOTCHES, SCRATCHES OR BENDING OF THE IMPLANT DURING THE COURSE OF SURGERY MAY ALSO CONTRIBUTE TO EARLY FAILURE. THESE PRECAUTIONS ARE STATED IN THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE DEVICE. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT REVISION SURGERY WAS PERFORMED BECAUSE TWO MONARCH PEDICLE SCREWS WERE BROKEN AT THE NECK OF EACH DEVICE. THE HEADS OF THE SCREWS WERE EXPLANTED. HOWEVER, THE SCREW SHANKS COULD NOT BE REMOVED AND REMAIN EMBEDDED IN THE PT'S VERTEBRAE. ADDITIONALLY, AS A RESULT OF THE DIFFICULTY, SURGERY WAS EXTENDED BY TWO HOURS. THERE WERE NO ADVERSE CONSEQUENCES TO THE PT. SEE MFG MEDWATCH REPORT# 1526439-2011-00134 FOR THE SECOND SCREW THAT WAS INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONARCH PEDICLE SCREW SPINAL FIXATION DEVICE MNI DEPUY SPINE, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention FOUR ADD'L MONARCH PEDICLE SCREWS PLUS RODS.| PRODUCT CODES ARE UNK.