BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPLESS LI PEDICLE 6.5-40MM SCREWS

    MDR report key: 1345561 · Received March 17, 2009

    Report

    Report Number
    3005031160-2009-00011
    Event Type
    Injury
    Date Received
    March 17, 2009
    Date of Event
    February 1, 2009
    Report Date
    March 3, 2009
    Manufacturer
    X-SPINE SYSTEMS, INC.
    Product Code
    MNI
    PMA / PMN Number
    K072282
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE X-RAYS RECEIVED CONFIRM THAT BOTH SIDES OF THE CONSTRUCT HAD DISASSOCIATED. DURING EVALUATION OF THE PRODUCTS RECEIVED FOR EVALUATION AS WELL AS PRODUCTS FROM THE X-SPINE INVENTORY FROM ONE OF THE SAME LOTS (77817), IT WAS FOUND THAT A DIMENSION ON ONE OF THE SCREW COMPONENTS WERE OUT OF THE SPECIFIED TOLERANCE. THIS DISCREPANT DIMENSION WILL PREVENT AN OPTIMAL COMPRESSION OF THE SCREW CONSTRUCT ONTO A ROD, AND MAY CAUSE A DISASSOCIATION OF THE CONSTRUCT IN SOME CIRCUMSTANCES. AN ADVISORY NOTICE HAS BEEN SENT OUT TO ALL DISTRIBUTORS AND HOSPITALS IN THE US, INDICATING THAT THE CAPLESS LI PRODUCTS SHOULD BE SENT BACK TO X-SPINE SYSTEMS.

    Description of Event or Problem · 1

    PROCEDURE TYPE: SPINAL SURGERY - FUSION L3 TO S1. ACCORDING TO THE REPORTER: INITIAL OPERATION WAS PERFORMED IN . AT ABOUT 10 DAYS LATER, THE PATIENT EXPERIENCED AN INCREASE IN PAIN. X-RAYS WERE TAKEN AT APPROXIMATELY ONE WEEK LATER, AND IT WAS CONFIRMED THAT ALL OF THE SCREWS (8) HAD DISASSOCIATED. A REVISION SURGERY WAS PERFORMED SUCCESSFULLY IN THE NEXT DAY. ACCORDING TO THE DOCTOR, THE PATIENT DID NOT HAVE ANY TRAUMA AND WAS WEARING A BRACE. NO INTERIOR COLUMN SUPPORT WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPLESS LI PEDICLE 6.5-40MM SCREWS PEDICLE SCREW SPINAL SYSTEM MNI X-SPINE SYSTEMS, INC. X010-0015 76594

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention MODEL# X010-0020| LOT# 77817| CAPLESS LI PEDICLE 7.5-35MM SCREWS