BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAW GUIDE SIZE 7/9

    MDR report key: 1932825 · Received December 2, 2010

    Report

    Report Number
    2249697-2010-01652
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 9, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LXH
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER, (B)(6) REPORTED VIA OUR SALES REP, (B)(4) THAT PART OF THE UNIT HAS SHEARED OFF. IT IS FURTHER REPORTED THAT THERE WAS NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAW GUIDE SIZE 7/9 INSTRUMENT LXH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other