BEUDAMED
    FDA Adverse Event Other Summary report: N

    TIBIAL NAIL 13X360 MM

    MDR report key: 1594686 · Received February 2, 2010

    Report

    Report Number
    9610622-2010-00044
    Event Type
    Other
    Date Received
    February 2, 2010
    Date of Event
    September 4, 2009
    Report Date
    January 15, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K813371
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON (B)(4) 2010, RAQA MANAGER FROM (B)(4) RECEIVED AN EMAIL ABOUT AN EVENT THAT OCCURRED ON (B)(6). ON (B)(6) 2009, A NURSE SENT AN EMAIL STATING THAT IN THE (B)(6) NAILS WERE BEING USED WITH MORE LOCKS THAN USUAL. SHE ASKED THE PRODUCT MANAGER IF THIS WAS A NORMAL PROCEDURE. SHE ASKED IF THE MEDICAL DEVICE COULD BE MODIFIED WITHOUT NOTIFYING THE MANUFACTURER OR SOME COMPETENT AUTHORITY. THE NURSE WAS TOLD THAT THE SURGEON HAS THE KNOWLEDGE FOR PERFORMING ANY OF THE MODIFICATIONS TO THE DEVICE HE MIGHT FIND USEFUL FOR THE PATIENT. THERE IS NO INFORMATION ABOUT THE PATIENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TIBIAL NAIL 13X360 MM IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL UNK K804748

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other