BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPEDIUIM THORACIC PEDICLE PROBE, CURVED

    MDR report key: 2992110 · Received March 7, 2013

    Report

    Report Number
    1526439-2013-13296
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 27, 2013
    Manufacturer
    DEPUY SYNTHES SPINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION FOUND THE TIP OF THE CURVED PEDICLE PROBE BROKEN AT THE 40MM GRADUATION MARK. REVIEW OF THE DHR IDENTIFIED NO ISSUES IDENTIFIED DURING THE MANUFACTURING AND RELEASE OF THIS PRODUCT THAT COULD BE ATTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. THE DEVICE HAS BEEN IN THE FIELD FOR APPROXIMATELY 8 YEARS. IT APPEARS THAT THE DEVICE MALFUNCTIONED DUE TO NORMAL WEAR AND TEAR. AT THIS TIME, THE COMPLAINT IS CONSIDERED TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION.

    Description of Event or Problem · 1

    INTERNATIONAL AFFILIATE REPORTS THE TIP OF THE PROBE BROKE DURING PEDICLE PREPARATION. REPORTS THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AND NO DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97123 EXPEDIUIM THORACIC PEDICLE PROBE, CURVED ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH DEPUY SYNTHES SPINE 0405V

    Patients

    Seq Age Sex Outcome Treatment
    1