BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURA DURATION A/P TIB LG 11

    MDR report key: 2231475 · Received July 22, 2011

    Report

    Report Number
    9616680-2011-00490
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 4, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JWH
    PMA / PMN Number
    K915512
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A (B)(4): DURA DURATION A/P TIB LG 11 FAILED TO CONNECT PROPERLY DURING AN OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURA DURATION A/P TIB LG 11 IMPLANT JWH STRYKER ORTHOPAEDICS CORK NA 29303601

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other