BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HRIS FLEXIBLE OSTEO .12X120MM

    MDR report key: 3840483 · Received May 30, 2014

    Report

    Report Number
    0002249697-2014-01973
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 5, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THE EVENT COULD NOT BE CONFIRMED NOR THE ROOT CAUSE OF THE REPORTED EVENT DETERMINED DUE TO THE MINIMAL INFORMATION RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REVISION OF REJUVENATE IMPLANTS WHILE REMOVING THE STEM AND USING THE FLEXIBLE OSTEOTOME THE SURGEON STARTED TO USE IT AND TOOK ONE HIT AND THE INSTRUMENT BROKE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE REVISION OF REJUVENATE IMPLANTS WHILE REMOVING THE STEM AND USING THE FLEXIBLE OSTEOTOME THE SURGEON STARTED TO USE IT AND TOOK ONE HIT AND THE INSTRUMENT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319421 HRIS FLEXIBLE OSTEO .12X120MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH X9E18

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other