BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASS LP

    MDR report key: 4240042 · Received November 10, 2014

    Report

    Report Number
    1000432246-2014-00007
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    May 27, 2014
    Report Date
    October 23, 2014
    Manufacturer
    MEDICREA INTERNATIONAL
    Product Code
    MNI
    PMA / PMN Number
    K123138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY OF RETURNED SCREW: THE TIP OF THE SCREW IS BROKEN. NO MATERIAL DEFECT NEAR THE BROKEN FACE WAS DETECTED. ON THE X-RAYS IT WAS NOTICED THAT THE SCREW WAS NOT COMPLETELY POSITIONED IN CONTACT WITH THE SACRUM. ONLY 1/3 OF THE LENGTH OF THE SCREW WAS IMPLANTED IN THE BONE. CONSEQUENTLY, THE TIP OF THE SCREW WAS SUBJECTED TO STRESS WHICH COULD BE THE CAUSE OF ITS BREAKAGE.

    Description of Event or Problem · 1

    PATIENT CAME BACK FOR FOLLOW-UP AFTER 16 MONTHS COMPLAINING OF PAIN. DOCTOR FOUND ONE SCREW BROKEN AT S1 ON THE LEFT SIDE. INITIALLY, SURGEON HADE STABILIZED THE SPINE FROM L3-S1 DUE TO SPINAL STENOSIS WITH AN EIGHT SCREW CONSTRUCT. SURGEON DECIDED TO REVISE AND REMOVED THE BROKEN SCREW AT S1 ON LEFT SIDE AND IMPLANTED A NEW SCREW, AND RE-LOCATED THE SCREW SLIGHTLY INFERIOR THAN BEFORE. THE SURGEON LEFT THE REMAINING SCREWS IN PLACE AND PUT BACK THE CONSTRUCT WITH NEW NUTS AND A SLIGHTLY LONGER ROD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724021 PASS LP POSTERIOR PEDICLE SCREW SYSTEM MNI MEDICREA INTERNATIONAL Ø6.5 MM X 40 MM 12I0168

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization