BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD HOLDER

    MDR report key: 2981698 · Received February 27, 2013

    Report

    Report Number
    1719045-2013-00421
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    January 29, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. INSTRUMEDICAL TECHNOLOGIES MANUFACTURED THE ROD INTRODUCER. THE PRODUCT CONFORMED TO ALL REQUIREMENTS. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION HAS SHOWN THAT THE COUPLING OF THE ROD IS DEFORMED. FURTHERMORE ARE TRACES OF WEAR VISIBLE ON THE TOP OF THE ROD. THIS DAMAGE CAUSED THAT THE ROD CAN NOT LOCK ACCORDINGLY. A POSSIBLE CAUSE FOR THIS DEFECT COULD BE BILATERAL HIGH FORCES ON THE TIP OF THE ROD DURING THE INTRODUCTION.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE ROD HOLDER CANNOT LOCK ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83481 ROD HOLDER HOLDER LXH SYNTHES MONUMENT 6795641

    Patients

    Seq Age Sex Outcome Treatment
    1