BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPACTOR ASSEMBLY OMEGA

    MDR report key: 2940707 · Received December 12, 2012

    Report

    Report Number
    8031020-2012-00296
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS SELZACH
    Product Code
    HWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE OPERATING ROOM MGR, REPORTED THAT DURING A SURGERY, WHILE IMPACTING, THE DEVICE FRACTURED. NO DELAY AND NO ADVERSE CONSEQUENCES FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPACTOR ASSEMBLY OMEGA INSTRUMENT HWA STRYKER OSTEOSYNTHESIS SELZACH NA W37470

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other