BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TISSUE PROTECTION SLEEVE, SHORT T2 TIBIA 9MM

    MDR report key: 2904773 · Received December 4, 2012

    Report

    Report Number
    9610622-2012-00551
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    November 13, 2012
    Report Date
    November 13, 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
    JA
    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. ADDITIONAL DEVICES: 1806-2035 TARGETING ARM T2 PROX. HUM. LOT # KHI112627; 1806-0180 TISSUE PROTECTION SLEEVE, SHORT T2 TIBIA 9MM LOT # K204875.

    Description of Event or Problem · 1

    DURING T2PH SURGERY THE GUIDE SLEEVE COULD NOT GO THROUGH THE 4TH HOLE OF THE TARGET DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TISSUE PROTECTION SLEEVE, SHORT T2 TIBIA 9MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA K806902

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other