BEUDAMED
    FDA Adverse Event Other Summary report: N

    TROCHANTERIC NAIL KIT, TI 11X180MM X 125

    MDR report key: 1623133 · Received March 3, 2010

    Report

    Report Number
    9610622-2010-00089
    Event Type
    Other
    Date Received
    March 3, 2010
    Date of Event
    January 8, 2010
    Report Date
    February 9, 2010
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    HSB
    PMA / PMN Number
    K034002
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED ON A SUPPLEMENT REPORT.

    Description of Event or Problem · 1

    WE RECEIVED THE ITEMS OF THIS PER ON (B)(4), 2010. MALE NURSE RAMAN REPORTED VIA OUR SALES REP, (B)(4), THAT HE STATED DURING THE SURGERY THAT THE SET SCREWS HAVE BEEN MISSING IN THE PACKAGE OF THE SET. ACCORDING TO HIS INFORMATION THE PATIENT WAS NOT IMPAIRED BY THIS EVENT AND THAT THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TROCHANTERIC NAIL KIT, TI 11X180MM X 125 IMPLANT HSB STRYKER OSTEOSYNTHESIS KIEL NA K184961/K

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other