BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOLA ILIAC SCREW PROBE STARTER

    MDR report key: 3000009 · Received March 12, 2013

    Report

    Report Number
    1526439-2013-13661
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 14, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL IS UNABLE TO LOCATE THE INSTRUMENT AND THE LOT CODE IS UNKNOWN. WITHOUT A LOT NUMBER, A REVIEW OF MANUFACTURING RECORDS CANNOT BE COMPLETED. WITHOUT A PRODUCT SAMPLE WE ARE UNABLE TO CONFIRM THE REPORTED ISSUE OR IDENTIFY THE ROOT CAUSE. REVIEW OF PRODUCT COMPLAINTS FOUND NO EMERGING TRENDS. IN THE ABSENCE OF A PRODUCT SAMPLE, LOT NUMBER, OR OBSERVED TREND, THIS COMPLAINT WILL BE CLOSED WITH NO FURTHER ACTION REQUIRED. IF THE COMPLAINT PRODUCT SAMPLE BECOMES AVAILABLE, THE COMPLAINT FILE WILL BE RE-OPENED AND THE PRODUCT EVALUATED. HOSPITAL UNABLE TO LOCATE THE DEVICE.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THAT DURING SURGERY ON AN ADULT PATIENT, THE PROBE WAS INSERTED INTO A LUMBAR PEDICLE. WHEN THE INSTRUMENT WAS TURNED, THE TIP OF THE PROBE BROKE OFF IN THE PEDICLE. THE BROKEN PORTION WAS REMOVED AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102978 ISOLA ILIAC SCREW PROBE STARTER ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE

    Patients

    Seq Age Sex Outcome Treatment
    1