BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TARGET DEVICE 300X160MM

    MDR report key: 1620907 · Received February 19, 2010

    Report

    Report Number
    9610622-2010-00067
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    January 25, 2010
    Report Date
    January 28, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENTAL REPORT. THESE TWO LOTS WERE ALSO REPORTED. IT IS NOT KNOWN WHICH ONE CAUSED THIS EVENT. LOT # KME901485, LOT# KP214125.

    Description of Event or Problem · 1

    EMPLOYEE OF THE HOSP, REPORTED VIA OUR SALES REP, THAT HE NOTICED DURING THE SURGERY THAT THE DISTAL DRILLING FAILED SEVERAL TIMES WITH TARGET DEVICES. HE MENTIONED THAT IT WAS NOT POSSIBLE TO MEET THE DRILL HOLES. ACCORDING TO HIS INFO THE SURGERY WAS COMPLETED SUCCESSFULLY BY USING A REPLACING TARGET DEVICE WITHOUT ANY PT IMPAIRMENT OR PROLONGATION OF THE SURGERY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TARGET DEVICE 300X160MM INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KP260304

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other