BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACER BLOCK HANDLE - 8MM/9MM

    MDR report key: 3124332 · Received May 22, 2013

    Report

    Report Number
    0002249697-2013-01751
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    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

    WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    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. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A PKR (RIGHT MEDIAL SIDE) THE 8/9 MM SPACER BLOCK HANDLE BROKE. SURGERY WAS COMPLETED WITHOUT DELAY OR CONSEQUENCE TO PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING A PKR (RIGHT MEDIAL SIDE) THE 8/9 MM SPACER BLOCK HANDLE BROKE. SURGERY WAS COMPLETED WITHOUT DELAY OR CONSEQUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225969 SPACER BLOCK HANDLE - 8MM/9MM INSTRUMENT LXH STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other