BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON ?11X34

    MDR report key: 2892195 · Received December 19, 2012

    Report

    Report Number
    9610622-2012-00600
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 28, 2012
    Report Date
    December 10, 2012
    Manufacturer
    STRYKER TRAUMA GMBH
    Product Code
    HSB
    PMA / PMN Number
    K102992
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD¿L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADDITIONAL DEVICES: 18976-110S LAG SCREW, RECON T2 RECON ?6.5X110 MM, LOT # K239905, 18965-050S LOCKING SCREW, FULLY THREADED T2 TIBIA ? 5X50 MM LOT # K226691, 18965-060S LOCKING SCREW, FULLY THREADED T2 TIBIA ? 5X60 MM LOT # K611549, 1843-1134S END CAP T2 RECON +15MM LOT # K269801.

    Description of Event or Problem · 1

    ON (B)(6) 2012, T2 RECON NAIL SURGERY WAS PERFORMED. THE NAIL WAS INSERTED IN THE AVOIDABLE STATE WITH INSUFFICIENT REDUCTION. ON (B)(6) 2012, IT WAS CONFIRMED THAT THE NAIL BROKE. THE REVISION SURGERY WITH UHA WAS PERFORMED ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECONSTRUCTION NAIL R1.5, TI, LEFT T2 RECON ?11X34 IMPLANT HSB STRYKER TRAUMA GMBH NA K130602

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R