BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAIL ADAPTER T2 RECON

    MDR report key: 2945752 · Received January 4, 2013

    Report

    Report Number
    9610622-2013-90003
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE

    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

    IT WAS REPORTED THAT THREADS IN THE RECON NAIL ADAPTOR WERE STRIPPED DURING THE IMPACTION OF THE NAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5658 NAIL ADAPTER T2 RECON INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA H108388

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other