BEUDAMED
    FDA Adverse Event Summary report: N

    FLAT PANEL SPRING ARM

    MDR report key: 2833806 · Received November 6, 2012

    Report

    Report Number
    2031963-2012-00154
    Date Received
    November 6, 2012
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    STRYKER COMMUNICATIONS
    Product Code
    BRY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PT INVOLVEMENT, THUS NO PT INFORMATION IS AVAILABLE. THE CATALOG NUMBER PROVIDED IS FOR THE HORIZONTAL ARM WHICH IS THE COMPONENT IDENTIFIED AS ALLEGEDLY HAVING A CRACKED WELD. A STRYKER FIELD SERVICE TECHNICIAN INITIALLY OBSERVED THE REPORTED EVENT AND IS SCHEDULED TO REPLACE THE FLAT PANEL AT THE USER FACILITY ONCE REPLACEMENT PARTS ARE AVAILABLE. THE COMPONENT WITH THE ALLEGED CRACKED WELD IS SCHEDULED TO BE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. DURING AN ON SITE SERVICE CALL, A STRYKER FIELD SERVICE TECHNICIAN FOUND THAT A WELD ON THE HORIZONTAL ARM OF THE FLAT PANEL WAS CRACKED. THERE WAS NO PT INVOLVEMENT AND NO REPORTED ADVERSE CONSEQUENCES. THE INVESTIGATION AS TO THE ROOT CAUSE OF THIS REPORTED ISSUE IS ONGOING.

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT THE HORIZONTAL ARM OF A SINGLE FLAT PANEL SUSPENSION ALLEGEDLY HAS A CRACK IN THE WELD. THERE WAS NO REPORTED PT INVOLVEMENT AND NO ADVERSE CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLAT PANEL SPRING ARM BRY STRYKER COMMUNICATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1